The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Abc-1000 Small Joint Reamers.
| Device ID | K862933 |
| 510k Number | K862933 |
| Device Name: | ABC-1000 SMALL JOINT REAMERS |
| Classification | Reamer |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Clyde T Marrangoni |
| Correspondent | Clyde T Marrangoni INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-04 |
| Decision Date | 1986-08-18 |