• 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, gas, anesthetic
510(k) Number K801251
Device Name NON-CONDUCTIVE, SINGLE USE FACE MASK #55
Applicant
VITAL SIGNS, INC.
1 MADISON ST.
EAST RUTHERFORD,  NJ  07073
Applicant Contact Terence D Wall
Correspondent
VITAL SIGNS, INC.
1 MADISON ST.
EAST RUTHERFORD,  NJ  07073
Correspondent Contact Terence D Wall
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received05/28/1980
Decision Date 06/04/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-