510(k) K851775
K851775 is an FDA 510(k) premarket notification submitted by Artiberia for the device "19-790 TO 19-1042 DRESSING/SPONGE FORCEPS". The FDA issued a decision of Substantially Equivalent on Jun 11, 1985. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. Artiberia has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 11, 1985
- Date Received
- Apr 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Forceps, Ent
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type
- 510(k) Exempt