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510(k) K880930

MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE by Copper Lasersonics, Inc. — Product Code HHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
March 4, 1988
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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