The following data is part of a premarket notification filed by American Medical Mfg., Inc. with the FDA for Plastic Disposable Surgical Light Handle Cover.
Device ID | K915068 |
510k Number | K915068 |
Device Name: | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER |
Classification | Light, Surgical, Accessories |
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 | FTA |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-08 |
Decision Date | 1992-02-06 |