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 |