The following data is part of a premarket notification filed by Generica Medical International, Inc. with the FDA for Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag Set.
| Device ID | K133077 |
| 510k Number | K133077 |
| Device Name: | GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | GENERICA MEDICAL INTERNATIONAL, INC. 1910 D ST. Laverne, CA 91750 |
| Contact | Jim Barley |
| Correspondent | Jim Barley GENERICA MEDICAL INTERNATIONAL, INC. 1910 D ST. Laverne, CA 91750 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859261004029 | K133077 | 000 |
| 20859261004036 | K133077 | 000 |
| 20859261004043 | K133077 | 000 |