510(k) K782006
K782006 is an FDA 510(k) premarket notification submitted by Med General for the device "MEDGENERAL SINGLE-USE BULLDOG". The FDA issued a decision of Substantially Equivalent on December 15, 1978. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Med General has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1978
- Date Received
- December 1, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type