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FDA 510(k), K911997, TENDERFOOT(R), MODIFICATION
FDA 510(k), K911997, TENDERFOOT(R), MODIFICATION
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510(K) Number: K911997
Device Name: TENDERFOOT(R), MODIFICATION
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: single use only blood lancet with an integral sharps injury prevention feature
Regulation Number: 878.4850
Classification Product Code: FMK
Date Received: 04/22/1991
Decision Date: 07/17/1991
Regulation Medical Specialty: General & Plastic Surgery
Device Name: TENDERFOOT(R), MODIFICATION
Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
Device Classification Name: single use only blood lancet with an integral sharps injury prevention feature
Regulation Number: 878.4850
Classification Product Code: FMK
Date Received: 04/22/1991
Decision Date: 07/17/1991
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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