The following data is part of a premarket notification filed by Gps with the FDA for Hospital's Clamp.
Device ID | K974227 |
510k Number | K974227 |
Device Name: | HOSPITAL'S CLAMP |
Classification | Clamp, Umbilical |
Applicant | GPS 11 LOWELL RD. Port Washington, NY 11050 |
Contact | Louis Pagliara |
Correspondent | Louis Pagliara GPS 11 LOWELL RD. Port Washington, NY 11050 |
Product Code | HFW |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-12 |
Decision Date | 1997-12-12 |