510(k) K873978
K873978 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "DISPOSABLE BIPOLAR FORCEPS". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. E.M. Adams has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1987
- Date Received
- September 30, 1987
- 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