The following data is part of a premarket notification filed by National-standard Medical Products with the FDA for Hydro-sil(tm) Coated Guidewires.
| Device ID | K900822 |
| 510k Number | K900822 |
| Device Name: | HYDRO-SIL(TM) COATED GUIDEWIRES |
| Classification | Fluorometer, Lead (dedicated Instruments) |
| Applicant | NATIONAL-STANDARD MEDICAL PRODUCTS 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz NATIONAL-STANDARD MEDICAL PRODUCTS 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
| Product Code | DOX |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-21 |
| Decision Date | 1990-07-17 |