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 Mask, Surgical
510(k) Number K911334
Device Name MASK, SURGICAL APPAREL
Applicant
Thai Hospital Products Co., Ltd.
173 Moo 5 Thatoom,
Srimahapothi
Prachinburi,  TH 25140
Applicant Contact THAWATCHAI MATURAPOR
Correspondent
Thai Hospital Products Co., Ltd.
173 Moo 5 Thatoom,
Srimahapothi
Prachinburi,  TH 25140
Correspondent Contact THAWATCHAI MATURAPOR
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/26/1991
Decision Date 08/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-