The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for General Medical Procedure Kit/skin Preparation.
| Device ID | K905463 |
| 510k Number | K905463 |
| Device Name: | GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz ANGIOSYSTEMS, INC. C/O MEDICAL DEVICE INSPECITON 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-01-22 |