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 Splint, Nasal
510(k) Number K942158
Device Name AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
Applicant
WFR/AQUAPLAST CORP.
P.O. BOX 635
WYCKOFF,  NJ  07481 -0635
Applicant Contact JOHN R KIRK
Correspondent
WFR/AQUAPLAST CORP.
P.O. BOX 635
WYCKOFF,  NJ  07481 -0635
Correspondent Contact JOHN R KIRK
Regulation Number874.5800
Classification Product Code
EPP  
Date Received05/03/1994
Decision Date 07/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-