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 Syringe, Cartridge
510(k) Number K960270
Device Name DENTALOGIC
Applicant
Protecs Syringes International Corp.
1247 Florida Ave.
Palm Harobor,  FL  34683
Applicant Contact PAT LAMB
Correspondent
Protecs Syringes International Corp.
1247 Florida Ave.
Palm Harobor,  FL  34683
Correspondent Contact PAT LAMB
Regulation Number872.6770
Classification Product Code
EJI  
Date Received01/18/1996
Decision Date 03/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-