The following data is part of a premarket notification filed by W.o.m. World Of Medicine, Gmbh with the FDA for Surgipump.
| Device ID | K935763 |
| 510k Number | K935763 |
| Device Name: | SURGIPUMP |
| Classification | Withdrawal/infusion Pump |
| Applicant | W.O.M. WORLD OF MEDICINE, GMBH C/O QUALITIVITY 8536 CALLE TIOGA Tucson, AZ 85704 -6508 |
| Contact | Owen B Lamb |
| Correspondent | Owen B Lamb W.O.M. WORLD OF MEDICINE, GMBH C/O QUALITIVITY 8536 CALLE TIOGA Tucson, AZ 85704 -6508 |
| Product Code | DQI |
| CFR Regulation Number | 870.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702002398 | K935763 | 000 |