The following data is part of a premarket notification filed by Hospi Corporation with the FDA for Macy Catheter.
Device ID | K133881 |
510k Number | K133881 |
Device Name: | MACY CATHETER |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | HOSPI CORPORATION 2384 GEHRINGER DRIVE Concord, CA 95420 |
Contact | Igal Ladabaum |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-12-20 |
Decision Date | 2014-01-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861003000202 | K133881 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MACY CATHETER 86401061 4742926 Live/Registered |
Hospi Corporation 2014-09-21 |