The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Hospital Disposables Spinal Manometer.
Device ID | K032432 |
510k Number | K032432 |
Device Name: | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER |
Classification | Manometer, Spinal-fluid |
Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 2156 Huntington, CT 06484 |
Contact | Joseph M Azary |
Correspondent | Joseph M Azary BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 2156 Huntington, CT 06484 |
Product Code | FMJ |
CFR Regulation Number | 880.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-06 |
Decision Date | 2003-08-28 |
Summary: | summary |