510(k) K821278
K821278 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "HARTMAN FORCEPS STRAIGHT 3 1/2". The FDA issued a decision of Substantially Equivalent on May 27, 1982. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Conphar, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1982
- Date Received
- May 3, 1982
- 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