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 Tube, Tracheal (W/Wo Connector)
510(k) Number K910463
Device Name MEROCEL(R) LASER-GUARD(TM)
Applicant
MEROCEL CORP.
950 FLANDERS RD.
MYSTIC,  CT  06355 -0334
Applicant Contact DOM L GATTO
Correspondent
MEROCEL CORP.
950 FLANDERS RD.
MYSTIC,  CT  06355 -0334
Correspondent Contact DOM L GATTO
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/25/1991
Decision Date 04/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-