510(k) BK060042
- Device
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Applicant
- Charter Medical, Ltd.
- 510(k) number
- BK060042
- Product code
- LPZ
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2008-10-03
- Date received
- 2006-07-19
- Regulation
- 510(k) Premarket Notification
- Classification name
- Container, Frozen Donor Tissue Storage
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code LPZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021702 | CRYOBAG, MODEL CB | Origen Biomedical, Inc. | 2002-08-06 |
| K915471 | CRYOBAG | Janus Biomedical, Inc. | 1994-03-02 |
| K863872 | TAMPER HAMPER | Hydro-Med Products, Inc. | 1987-02-10 |
| K861761 | ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE | Travenol Laboratories, S.A. | 1986-08-28 |
| K860511 | AMPU-PAK | Ammerman Medical Enterprises, Inc. | 1986-08-04 |
| K853663 | ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR | Travenol Laboratories, S.A. | 1986-04-09 |
Legacy Summary#
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FDA Review#
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