MODEL 770 ARGON LASER

Powered Laser Surgical Instrument

SPECTRA-PHYSICS, INC.

The following data is part of a premarket notification filed by Spectra-physics, Inc. with the FDA for Model 770 Argon Laser.

Pre-market Notification Details

Device IDK781453
510k NumberK781453
Device Name:MODEL 770 ARGON LASER
ClassificationPowered Laser Surgical Instrument
Applicant SPECTRA-PHYSICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-22
Decision Date1978-10-24

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