The following data is part of a premarket notification filed by Ammerman Medical Enterprises, Inc. with the FDA for Ampu-pak.
| Device ID | K860511 |
| 510k Number | K860511 |
| Device Name: | AMPU-PAK |
| Classification | Container, Frozen Donor Tissue Storage |
| Applicant | AMMERMAN MEDICAL ENTERPRISES, INC. 1180 OLEANDER DR. Naples, FL 33940 |
| Contact | Anderson M.d. |
| Correspondent | Anderson M.d. AMMERMAN MEDICAL ENTERPRISES, INC. 1180 OLEANDER DR. Naples, FL 33940 |
| Product Code | LPZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-08-04 |