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510(k) K875039

ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY by Surgilase, Inc. — Product Code LNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1988
Date Received
December 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

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  • K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE (March 25, 1988)
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