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 Retainer, Surgical
510(k) Number K893870
Device Name ADAMS BREAST IMPLANT PROTECTOR
Applicant
Adept-Med Intl., Inc.
3293 Saratoga Ln.
P.O. Box 1777
Cameron Park,  CA  95682
Applicant Contact KATHLEEN QUIGLEY
Correspondent
Adept-Med Intl., Inc.
3293 Saratoga Ln.
P.O. Box 1777
Cameron Park,  CA  95682
Correspondent Contact KATHLEEN QUIGLEY
Regulation Number878.4800
Classification Product Code
GCZ  
Date Received05/26/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-