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510(k) K875314

GL-35 COLPOSCOPIC LASER SYSTEM by Laser Engineering, Inc. — Product Code HHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1988
Date Received
December 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

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Other clearances for product code HHR

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