510(k) K770652
K770652 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "FLUORESCENCE ILLUMINATOR ACCESSORY". The FDA issued a decision of Substantially Equivalent on July 6, 1977. The device falls under product code IBK (Microscope, Fluorescence/U.V.), a Class I device regulated under 21 CFR 864.3600. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1977
- Date Received
- April 6, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microscope, Fluorescence/U.V.
- Device Class
- Class I
- Regulation Number
- 864.3600
- Review Panel
- PA
- Submission Type