The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Aquaplast Tie Down Dressing.
| Device ID | K943871 |
| 510k Number | K943871 |
| Device Name: | AQUAPLAST TIE DOWN DRESSING |
| Classification | Guard, Skin Graft |
| Applicant | WFR/AQUAPLAST CORP. P.O. BOX 635 Wyckoff, NJ 07481 -0635 |
| Contact | John R Kirk |
| Correspondent | John R Kirk WFR/AQUAPLAST CORP. P.O. BOX 635 Wyckoff, NJ 07481 -0635 |
| Product Code | LZM |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-08 |
| Decision Date | 1994-09-30 |