The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Spectronic 1001 - Clinical Spectrophotometer.
Device ID | K850708 |
510k Number | K850708 |
Device Name: | SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Contact | Nicholas A Walp |
Correspondent | Nicholas A Walp BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-22 |
Decision Date | 1985-03-11 |