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 Sponge, Ophthalmic
510(k) Number K910707
Device Name OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
Applicant
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Applicant Contact CRAIG RAPP
Correspondent
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129
Correspondent Contact CRAIG RAPP
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received02/20/1991
Decision Date 04/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-