The following data is part of a premarket notification filed by American Medical Mfg., Inc. with the FDA for Ammi Magni-guard.
| Device ID | K961454 |
| 510k Number | K961454 |
| Device Name: | AMMI MAGNI-GUARD |
| Classification | Accessory, Surgical Apparel |
| Applicant | AMERICAN MEDICAL MFG., INC. 9410 DESOTO AVE., UNIT J Chatsworth, CA 91311 |
| Contact | Mike Hoftman |
| Correspondent | Mike Hoftman AMERICAN MEDICAL MFG., INC. 9410 DESOTO AVE., UNIT J Chatsworth, CA 91311 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-07-25 |
| Summary: | summary |