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 chamber, hyperbaric
510(k) Number K861315
Device Name HYPERBARIC PENETRATION EXTENSION SET
Applicant
CUTTER LABORATORIES, INC.
FOURTH AND PARKER STREETS
BOX 1986
BERKELEY,  CA  94710
Applicant Contact STEVEN J OJALA
Correspondent
CUTTER LABORATORIES, INC.
FOURTH AND PARKER STREETS
BOX 1986
BERKELEY,  CA  94710
Correspondent Contact STEVEN J OJALA
Regulation Number868.5470
Classification Product Code
CBF  
Date Received04/08/1986
Decision Date 05/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-