MEDIFLEX INJECTION CAP
FDA 510(k) clearance K855039 · decided 1986-01-24
Clearance details
- K-number
- K855039
- Device name
- MEDIFLEX INJECTION CAP
- Applicant
- Mediflex Intl.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-17
- Decision date
- 1986-01-24
- Days to decision
- 38 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
- Pine Brook, NJ, 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 |
| KLEIN CORK(TM) (K901715) | Jeff Klein Surgical, Inc. | 1990-05-11 |
| BETA-CAP II ADAPTER (K801680) | Quinton, Inc. | 1980-08-04 |
Recalls involving this device
No recalls on record reference this clearance.