The following data is part of a premarket notification filed by American Microptiks, Inc. with the FDA for Amo Arthoscopes.
| Device ID | K962330 |
| 510k Number | K962330 |
| Device Name: | AMO ARTHOSCOPES |
| Classification | Arthroscope |
| Applicant | AMERICAN MICROPTIKS, INC. 420 E. MAIN ST. BLDG.1/UNIT 10 Branford, CT 06405 |
| Contact | George Hallack |
| Correspondent | George Hallack AMERICAN MICROPTIKS, INC. 420 E. MAIN ST. BLDG.1/UNIT 10 Branford, CT 06405 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B192300311000 | K962330 | 000 |
| B192300012000 | K962330 | 000 |
| B192300011000 | K962330 | 000 |
| B192300010000 | K962330 | 000 |
| B192300008000 | K962330 | 000 |
| B192300006000 | K962330 | 000 |
| B192300004000 | K962330 | 000 |
| B192300003000 | K962330 | 000 |