510(k) K760605
K760605 is an FDA 510(k) premarket notification submitted by Merck, Sharp & Dohme for the device "LIGHTCAST II CARBIDE BLADE". The FDA issued a decision of Substantially Equivalent on Oct 5, 1976. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Merck, Sharp & Dohme has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 1976
- Date Received
- Sep 8, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Blade, Scalpel
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt