The following data is part of a premarket notification filed by Zerowet, Inc. with the FDA for Zerowet Splashield.
| Device ID | K974288 |
| 510k Number | K974288 |
| Device Name: | ZEROWET SPLASHIELD |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | ZEROWET, INC. P.O. BOX 4375 Palos Verdes Peninsula, CA 90274 |
| Contact | Keith Stamler |
| Correspondent | Keith Stamler ZEROWET, INC. P.O. BOX 4375 Palos Verdes Peninsula, CA 90274 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-14 |
| Decision Date | 1998-01-29 |
| Summary: | summary |