SLT CONTACT LASER SYSTEMS (GYNECOLOGY)

Powered Laser Surgical Instrument

SURGICAL LASER TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Contact Laser Systems (gynecology).

Pre-market Notification Details

Device IDK892346
510k NumberK892346
Device Name:SLT CONTACT LASER SYSTEMS (GYNECOLOGY)
ClassificationPowered Laser Surgical Instrument
Applicant SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern,  PA  19355
ContactGifford, R.n.
CorrespondentGifford, R.n.
SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-05
Decision Date1989-05-01

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