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 Mask, Surgical
510(k) Number K971744
Device Name FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
Applicant
Berkley Medical Resources, Inc.
31 Innsbrook Rd.
Asheville,  NC  28804
Applicant Contact FRANK R DASTOLI
Correspondent
Berkley Medical Resources, Inc.
31 Innsbrook Rd.
Asheville,  NC  28804
Correspondent Contact FRANK R DASTOLI
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/12/1997
Decision Date 07/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-