The following data is part of a premarket notification filed by Secure Medical Products, Inc. with the FDA for Secure Eva Dual Chamber Mixing Bag.
| Device ID | K960581 |
| 510k Number | K960581 |
| Device Name: | SECURE EVA DUAL CHAMBER MIXING BAG |
| Classification | Container, I.v. |
| Applicant | SECURE MEDICAL PRODUCTS, INC. 369 N. NEWCOMB ST. Whitewater, WI 53190 |
| Contact | Lisa M Beck |
| Correspondent | Lisa M Beck SECURE MEDICAL PRODUCTS, INC. 369 N. NEWCOMB ST. Whitewater, WI 53190 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50812496011522 | K960581 | 000 |
| 50812496011492 | K960581 | 000 |
| 50812496011515 | K960581 | 000 |
| 50812496011539 | K960581 | 000 |
| 50085412477461 | K960581 | 000 |
| 50085412477478 | K960581 | 000 |
| 50812496011461 | K960581 | 000 |
| 50812496011485 | K960581 | 000 |
| 50812496011508 | K960581 | 000 |
| 50812496011478 | K960581 | 000 |