510(k) K791105

B & L OPHTHALMIC CHAIR by Bausch & Lomb, Inc. — Product Code HMF

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