TOOTH PRESERVING SYSTEM
FDA 510(k) clearance K875221 · decided 1988-04-14
Clearance details
- K-number
- K875221
- Device name
- TOOTH PRESERVING SYSTEM
- Applicant
- Biological Rescue Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-22
- Decision date
- 1988-04-14
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- KJF
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Pottstown, PA, 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 |
|---|---|---|
| LIFECELL RECOVERY CONTAINER (K893787) | Baxter Healthcare Corp | 1989-06-23 |
| AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY (K892645) | Amicon, Inc. | 1989-06-13 |
| CELL (K780305) | Dynatech Laboratories, Inc. | 1978-03-27 |
Recalls involving this device
No recalls on record reference this clearance.