Clearance Summary
KSEA DE LA PLAZA BLEPHAROPLASTY SET received FDA 510(k) clearance under submission number K991592, sponsored by KARL STORZ Endoscopy-America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-11-02.
- Submission: K991592
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1999-11-02
Classification & Regulation
This clearance is catalogued under FDA product code HNI and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.