The following data is part of a premarket notification filed by Precision Optics Corp. with the FDA for Poc Arthroscope And Accessories.
| Device ID | K945684 |
| 510k Number | K945684 |
| Device Name: | POC ARTHROSCOPE AND ACCESSORIES |
| Classification | Arthroscope |
| Applicant | PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
| Contact | James A Reilly |
| Correspondent | James A Reilly PRECISION OPTICS CORP. 22 EAST BROADWAY Gardner, MA 01440 -3338 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856164008198 | K945684 | 000 |
| 00856164008181 | K945684 | 000 |