510(k) K895434
K895434 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "ALCON FOLDING FORCEPS". The FDA issued a decision of Substantially Equivalent on December 4, 1989. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Alcon Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1989
- Date Received
- September 8, 1989
- 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