The following data is part of a premarket notification filed by Zerowet Splashield with the FDA for Zerowet Splashield.
| Device ID | K900208 |
| 510k Number | K900208 |
| Device Name: | ZEROWET SPLASHIELD |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | ZEROWET SPLASHIELD 1715 VIA EL PRADO P.O. BOX 7000-16 Redondo Beach, CA 90277 |
| Contact | Stamler, Md |
| Correspondent | Stamler, Md ZEROWET SPLASHIELD 1715 VIA EL PRADO P.O. BOX 7000-16 Redondo Beach, CA 90277 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-09-04 |