510(k) K791105
K791105 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "B & L OPHTHALMIC CHAIR". The FDA issued a decision of Substantially Equivalent on July 24, 1979. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1979
- Date Received
- June 13, 1979
- 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