• 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 implant, muscle, pectoralis
510(k) Number K944163
Device Name SPECTRUM DISIGNS PECTORAL IMPLANT
Applicant
SPECTRUM DESIGNS, INC.
5921-C MATTHEWS ST.
GOLETA,  CA  93117
Applicant Contact JIM DISHMAN
Correspondent
SPECTRUM DESIGNS, INC.
5921-C MATTHEWS ST.
GOLETA,  CA  93117
Correspondent Contact JIM DISHMAN
Regulation Number874.3620
Classification Product Code
MIC  
Date Received08/26/1994
Decision Date 11/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-