DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI
FDA 510(k) clearance K800318 · decided 1980-03-10
Clearance details
- K-number
- K800318
- Device name
- DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-12
- Decision date
- 1980-03-10
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- HBT
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, 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 |
|---|---|---|
| REFLEX(R) ECA (K924929) | Richard-Allan Medical | 1993-07-21 |
| TITANIUM LIGATING CLIPS (K896262) | Richard-Allan Medical Ind., Inc. | 1990-01-02 |
| TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP (K862696) | Downs Surgical , Ltd. | 1986-07-30 |
Recalls involving this device
No recalls on record reference this clearance.