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 Scraper, Tongue
510(k) Number K971025
Device Name AYURVEDIC TONGUE CLEANER
Applicant
CALELLO MARTINEZ P.C.
675 FRANKLIN AVE.
NUTLEY,  NJ  07110 -1209
Applicant Contact ANTONIO C MARTINEZ, II
Correspondent
CALELLO MARTINEZ P.C.
675 FRANKLIN AVE.
NUTLEY,  NJ  07110 -1209
Correspondent Contact ANTONIO C MARTINEZ, II
Regulation Number872.6855
Classification Product Code
LCN  
Date Received03/20/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-