The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Percutaneous Pigtail Suprapublic Catheter Set.
Device ID | K852287 |
510k Number | K852287 |
Device Name: | PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET |
Classification | Catheter, Suprapubic (and Accessories) |
Applicant | COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Contact | Dexter J Elkins |
Correspondent | Dexter J Elkins COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Product Code | KOB |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-29 |
Decision Date | 1985-08-08 |