The following data is part of a premarket notification filed by Storz Ophthalmics, Inc. with the FDA for Stors Scleral Sponge Ii (lincoff Design).
| Device ID | K950599 |
| 510k Number | K950599 |
| Device Name: | STORS SCLERAL SPONGE II (LINCOFF DESIGN) |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | STORZ OPHTHALMICS, INC. 21 PARK PLACE BLVD. NORTH Clearwater, FL 34619 -3917 |
| Contact | Nancy S Coulson |
| Correspondent | Nancy S Coulson STORZ OPHTHALMICS, INC. 21 PARK PLACE BLVD. NORTH Clearwater, FL 34619 -3917 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-03-02 |