The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Slip-coat(tm) Catheters.
Device ID | K882796 |
510k Number | K882796 |
Device Name: | SLIP-COAT(TM) CATHETERS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Contact | April Lavender |
Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-06 |
Decision Date | 1988-07-28 |