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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Surgical, Gynecologic
510(k) Number K880591
Device Name LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
Applicant
LASER PERIPHERALS LLC.
35 POND PARK RD. #9
HINGHAM,  MA  02043
Applicant Contact MICHAEL N BASEL
Correspondent
LASER PERIPHERALS LLC.
35 POND PARK RD. #9
HINGHAM,  MA  02043
Correspondent Contact MICHAEL N BASEL
Regulation Number884.4550
Classification Product Code
HHR  
Date Received02/11/1988
Decision Date 06/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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