The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Scleral Buckling Implants Dif/types.
| Device ID | K832481 |
| 510k Number | K832481 |
| Device Name: | SCLERAL BUCKLING IMPLANTS DIF/TYPES |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | STORZ INSTRUMENT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-26 |
| Decision Date | 1983-09-20 |