Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-