AMPU-PAK
FDA 510(k) clearance K860511 · decided 1986-08-04
Clearance details
- K-number
- K860511
- Device name
- AMPU-PAK
- Applicant
- Ammerman Medical Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-11
- Decision date
- 1986-08-04
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- LPZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ammerman Medical Enterprises
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CRYOBAG, MODEL CB (K021702) | Origen Biomedical, Inc. | 2002-08-06 |
| CRYOBAG (K915471) | Janus Biomedical, Inc. | 1994-03-02 |
| TAMPER HAMPER (K863872) | Hydro-Med Products, Inc. | 1987-02-10 |
| ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (K861761) | Travenol Laboratories, S.A. | 1986-08-28 |
| ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (K853663) | Travenol Laboratories, S.A. | 1986-04-09 |
Recalls involving this device
No recalls on record reference this clearance.