510(k) K821122
K821122 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT". The FDA issued a decision of Substantially Equivalent on May 7, 1982. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1982
- Date Received
- Apr 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cutter, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt