510(k) K832073
K832073 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "ELECTRIC INSTRUMENT TABLE". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. CooperVision, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1983
- Date Received
- June 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stand, Instrument, Ac-Powered, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1860
- Review Panel
- OP
- Submission Type