510(k) K861141
K861141 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "MANUAL OPHTHALMIC SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on April 24, 1986. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. CooperVision, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 1986
- Date Received
- March 26, 1986
- 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