The following data is part of a premarket notification filed by Panpac Medical Corporation with the FDA for Panpac Vaginal Pessary.
Device ID | K092981 |
510k Number | K092981 |
Device Name: | PANPAC VAGINAL PESSARY |
Classification | Pessary, Vaginal |
Applicant | Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
Contact | Yen-ming Pan |
Correspondent | Yen-ming Pan Panpac Medical Corporation NO. 202, 6F-1.2, SEC.3 TATONG ROAD Shi-chih City, Taipei Hsien, TW 22103 |
Product Code | HHW |
CFR Regulation Number | 884.3575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-28 |
Decision Date | 2010-07-22 |