The following data is part of a premarket notification filed by New York Blood Center, Inc. with the FDA for Mel-pak General Drug Delivery System Kit.
| Device ID | K894787 |
| 510k Number | K894787 |
| Device Name: | MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT |
| Classification | Set, Administration, Intravascular |
| Applicant | NEW YORK BLOOD CENTER, INC. BOX 5119 155 DURYEA ROAD Melville, NY 11747 |
| Contact | Martin H Stryker |
| Correspondent | Martin H Stryker NEW YORK BLOOD CENTER, INC. BOX 5119 155 DURYEA ROAD Melville, NY 11747 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-09-13 |