KLEIN CORK(TM)
FDA 510(k) clearance K901715 · decided 1990-05-11
Clearance details
- K-number
- K901715
- Device name
- KLEIN CORK(TM)
- Applicant
- Jeff Klein Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-13
- Decision date
- 1990-05-11
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GCE
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Clemente, CA, 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 |
|---|---|---|
| KLEIN CONNECTOR(TM) (K901716) | Jeff Klein Surgical, Inc. | 1990-05-11 |
| MEDIFLEX INJECTION CAP (K855039) | Mediflex Intl. | 1986-01-24 |
| BETA-CAP II ADAPTER (K801680) | Quinton, Inc. | 1980-08-04 |
Recalls involving this device
No recalls on record reference this clearance.