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 cannula, nasal, oxygen
510(k) Number K884149
Device Name COMFORT STRAP
Applicant
COMFORT STRAP CO.
212 SECOND AVE EAST
EGAN,  SD  57024 -9701
Applicant Contact ROD CLARK
Correspondent
COMFORT STRAP CO.
212 SECOND AVE EAST
EGAN,  SD  57024 -9701
Correspondent Contact ROD CLARK
Regulation Number868.5340
Classification Product Code
CAT  
Date Received10/03/1988
Decision Date 10/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-