The following data is part of a premarket notification filed by American Medical Corp. with the FDA for Disposable Needle Counters & Disposable Systems.
| Device ID | K915067 |
| 510k Number | K915067 |
| Device Name: | DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS |
| Classification | Container, Sharps |
| Applicant | AMERICAN MEDICAL CORP. 22231 MULHOLLAND HWY Woodland Hills, CA 91364 |
| Contact | Mike Hoftman |
| Correspondent | Mike Hoftman AMERICAN MEDICAL CORP. 22231 MULHOLLAND HWY Woodland Hills, CA 91364 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-03-11 |