The following data is part of a premarket notification filed by Mark One Healthcare Products with the FDA for Multiple-various Types Of Absorbent Incontinence.
| Device ID | K891986 |
| 510k Number | K891986 |
| Device Name: | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE |
| Classification | Bedding, Disposable, Medical |
| Applicant | MARK ONE HEALTHCARE PRODUCTS 100 E. 9TH AVE. P.O. BOX 160 Runnemede, NJ 08078 |
| Contact | Barry A Morse |
| Correspondent | Barry A Morse MARK ONE HEALTHCARE PRODUCTS 100 E. 9TH AVE. P.O. BOX 160 Runnemede, NJ 08078 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-12-29 |