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 spud, ophthalmic
510(k) Number K931449
Device Name MSP OPHTHALMIC (EYE SPUD)
Applicant
MEDICAL STERILE PRODUCTS, INC.
P.O. BOX 338
BO. ENSENADA ROAD 413, KM 0.2
RINCON,  PR  00677 -0338
Applicant Contact DAVID WISHINSKY
Correspondent
MEDICAL STERILE PRODUCTS, INC.
P.O. BOX 338
BO. ENSENADA ROAD 413, KM 0.2
RINCON,  PR  00677 -0338
Correspondent Contact DAVID WISHINSKY
Regulation Number886.4350
Classification Product Code
HNA  
Date Received03/23/1993
Decision Date 08/31/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-