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DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

DEN980001 Class II Post-NSE
Decision Date
1998-05-29
Sponsor / Applicant
Cranial Technologies, Inc.

Technical Specification

510(k) Submission ID DEN980001
Product Code MVA
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5970
Decision Date 1998-05-29
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND received FDA 510(k) clearance under submission number DEN980001, sponsored by Cranial Technologies, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1998-05-29.

Classification & Regulation

This clearance is catalogued under FDA product code MVA and 21 CFR 882.5970, within the Neurology review panel as a Class II device.