The following data is part of a premarket notification filed by Belmont Instrument Corp. with the FDA for Transport Cart.
Device ID | K952576 |
510k Number | K952576 |
Device Name: | TRANSPORT CART |
Classification | System, Balloon, Intra-aortic And Control |
Applicant | BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
Contact | Uraiwan P Labadini |
Correspondent | Uraiwan P Labadini BELMONT INSTRUMENT CORP. 780 BOSTON RD. Billerica, MA 01821 |
Product Code | DSP |
CFR Regulation Number | 870.3535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-05 |
Decision Date | 1995-12-26 |