The following data is part of a premarket notification filed by American Medical Mfg., Inc. with the FDA for Disposable Cautery Abrasive Pad.
| Device ID | K915064 |
| 510k Number | K915064 |
| Device Name: | DISPOSABLE CAUTERY ABRASIVE PAD |
| Classification | Instrument, Surgical, Disposable |
| Applicant | AMERICAN MEDICAL MFG., INC. 22231 MULHOLLAND HWY. Calabasas, CA 91302 |
| Contact | Mike Hoftman |
| Correspondent | Mike Hoftman AMERICAN MEDICAL MFG., INC. 22231 MULHOLLAND HWY. Calabasas, CA 91302 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-03-11 |