The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for Needle-grabber.
Device ID | K923840 |
510k Number | K923840 |
Device Name: | NEEDLE-GRABBER |
Classification | Guide, Needle, Surgical |
Applicant | GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington, DC 20004 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington, DC 20004 |
Product Code | GDF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-31 |
Decision Date | 1993-07-13 |