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 Pessary, Vaginal
510(k) Number K173351
Device Name Panpac Flexi Shelf Pessary
Applicant
Panpac Medical Corporation
6f-1,-2, #202, Sec.3, Ta-Tong Rd.
Shi-Chih Dist.,  TW 22103
Applicant Contact Yen-Ming Pan
Correspondent
Panpac Medical Corporation
6f-1,-2, #202, Sec.3, Ta-Tong Rd.
Shi-Chih Dist.,  TW 22103
Correspondent Contact Yen-Ming Pan
Regulation Number884.3575
Classification Product Code
HHW  
Date Received10/25/2017
Decision Date 10/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-