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 Guide, Surgical, Instrument
510(k) Number K914715
Device Name PARALLELING GUIDES
Applicant
Implant Corp. of America
2299 9th Ave. N., Suite 1-E
St. Petersburg,  FL  33713
Applicant Contact O.HILT TATUM
Correspondent
Implant Corp. of America
2299 9th Ave. N., Suite 1-E
St. Petersburg,  FL  33713
Correspondent Contact O.HILT TATUM
Regulation Number878.4800
Classification Product Code
FZX  
Date Received10/18/1991
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-