510(k) K821292
K821292 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "TONSIL SCISSORS 7". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code EGN (Scissors, Surgical Tissue, Dental), a Class I device regulated under 21 CFR 872.4565. Conphar, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1982
- Date Received
- May 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scissors, Surgical Tissue, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type