The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Aquaplast Nasal Splints, Precut Silver Splint Patterns And Splint Kits.
| Device ID | K942158 |
| 510k Number | K942158 |
| Device Name: | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS |
| Classification | Splint, Nasal |
| 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 | EPP |
| CFR Regulation Number | 874.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-03 |
| Decision Date | 1994-07-29 |