The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Jamshidi Marrow Acquisition Cradle.
Device ID | K003370 |
510k Number | K003370 |
Device Name: | JAMSHIDI MARROW ACQUISITION CRADLE |
Classification | Instrument, Biopsy |
Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Contact | Lavenia Ford |
Correspondent | Lavenia Ford ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-30 |
Decision Date | 2000-11-22 |