The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Minigard Disposable Liners.
Device ID | K840755 |
510k Number | K840755 |
Device Name: | MINIGARD DISPOSABLE LINERS |
Classification | Garment, Protective, For Incontinence |
Applicant | IPCO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EYQ |
CFR Regulation Number | 876.5920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-23 |
Decision Date | 1984-04-13 |