510(k) K792100
K792100 is an FDA 510(k) premarket notification submitted by Eder Instrument Co, Inc. for the device "GRASPING FORCEP (W/FOUR PRONGS)". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Eder Instrument Co, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1979
- Date Received
- October 19, 1979
- 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