ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
FDA 510(k) clearance K853663 · decided 1986-04-09
Clearance details
- K-number
- K853663
- Device name
- ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-03
- Decision date
- 1986-04-09
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- LPZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |
| AMPU-PAK (K860511) | Ammerman Medical Enterprises, Inc. | 1986-08-04 |
Recalls involving this device
No recalls on record reference this clearance.