The following data is part of a premarket notification filed by American Medical Mfg., Inc. with the FDA for Sharps Collection Container - Saf-t-shell.
| Device ID | K982029 |
| 510k Number | K982029 |
| Device Name: | SHARPS COLLECTION CONTAINER - SAF-T-SHELL |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-09 |
| Decision Date | 1999-04-06 |
| Summary: | summary |