Clearance Summary
NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS received FDA 510(k) clearance under submission number K875319, sponsored by I-Tech Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-01-22.
- Submission: K875319
- Applicant / Sponsor: I-Tech Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1988-01-22
Classification & Regulation
This clearance is catalogued under FDA product code GEN and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.