510(k) K851795
K851795 is an FDA 510(k) premarket notification submitted by Artiberia for the device "41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. Artiberia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1985
- Date Received
- April 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