K991592 is an FDA 510(k) clearance for the KSEA DE LA PLAZA BLEPHAROPLASTY SET. This device is classified as a Retractor, Ophthalmic (Class I - General Controls, product code HNI).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 2, 1999, 179 days after receiving the submission on May 7, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K991592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1999 |
| Decision Date | November 02, 1999 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNI — Retractor, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |