510(k) K851791
K851791 is an FDA 510(k) premarket notification submitted by Artiberia for the device "37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS". The FDA issued a decision of Substantially Equivalent on May 30, 1985. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Artiberia has 78 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1985
- Date Received
- Apr 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Forceps, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type
- 510(k) Exempt