The following data is part of a premarket notification filed by Paul Hartmann Corp. with the FDA for Ria Panty Shields.
Device ID | K843401 |
510k Number | K843401 |
Device Name: | RIA PANTY SHIELDS |
Classification | Pad, Menstrual, Unscented |
Applicant | PAUL HARTMANN CORP. P.O. BOX 1161 Greenwood , SC 29646 - |
Contact | Robert L Crawford |
Correspondent | Robert L Crawford PAUL HARTMANN CORP. P.O. BOX 1161 Greenwood , SC 29646 - |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-30 |
Decision Date | 1984-10-15 |