510(k) K771624
K771624 is an FDA 510(k) premarket notification submitted by J. Jamner Surgical Instruments, Inc. for the device "COPE LUNG FORCEPS #305-218". The FDA issued a decision of Substantially Equivalent on September 6, 1977. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. J. Jamner Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 1977
- Date Received
- August 25, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type