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 |