510(k) K851796
K851796 is an FDA 510(k) premarket notification submitted by Artiberia for the device "51-210 TO 51-352 VARIOUS INTEST FOR CALLIS, LOCKWO". The FDA issued a decision of Substantially Equivalent on Jun 20, 1985. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Artiberia has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 20, 1985
- Date Received
- Apr 25, 1985
- 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
- 510(k) Exempt