The following data is part of a premarket notification filed by Clinipad Corp. with the FDA for I.v. Start Kit.
Device ID | K932071 |
510k Number | K932071 |
Device Name: | I.V. START KIT |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
Contact | Patricia Stawarz |
Correspondent | Patricia Stawarz CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
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 | 1993-04-28 |
Decision Date | 1994-02-17 |