The following data is part of a premarket notification filed by Clay Kennard with the FDA for Pediatric Urinary Catheter.
Device ID | K060268 |
510k Number | K060268 |
Device Name: | PEDIATRIC URINARY CATHETER |
Classification | Catheter, Urethral |
Applicant | CLAY KENNARD 2909 BROWNE STONE ROAD Oklahoma City, OK 73120 |
Contact | Clay Kennard |
Correspondent | Clay Kennard CLAY KENNARD 2909 BROWNE STONE ROAD Oklahoma City, OK 73120 |
Product Code | GBM |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-01 |
Decision Date | 2006-02-24 |
Summary: | summary |