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 |