The following data is part of a premarket notification filed by Optical Integrity, Inc. with the FDA for Optical Integrity General Shaped Fiber.
| Device ID | K022338 |
| 510k Number | K022338 |
| Device Name: | OPTICAL INTEGRITY GENERAL SHAPED FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OPTICAL INTEGRITY, INC. 8317 FRONT BEACH RD. SUITE 21 Panama City Beach, FL 32407 -4893 |
| Contact | Joe D Brown |
| Correspondent | Joe D Brown OPTICAL INTEGRITY, INC. 8317 FRONT BEACH RD. SUITE 21 Panama City Beach, FL 32407 -4893 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2002-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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