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 Colposcope (And Colpomicroscope)
510(k) Number K871682
Device Name WALLACH CONVERTIBLE COLPOSCOPE
Applicant
Wallach Surgical Devices, Inc.
291 Pepe'S Farm Rd.
Milford,  CT  06460
Applicant Contact VINCENT FRAZZETTA
Correspondent
Wallach Surgical Devices, Inc.
291 Pepe'S Farm Rd.
Milford,  CT  06460
Correspondent Contact VINCENT FRAZZETTA
Regulation Number884.1630
Classification Product Code
HEX  
Date Received04/29/1987
Decision Date 06/24/1987
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
-
-