The following data is part of a premarket notification filed by Global Medical Prods, Inc. with the FDA for Global Medical Products Tuohy & Crawford Epidural Needle W/plastic Hub.
Device ID | K952275 |
510k Number | K952275 |
Device Name: | GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | GLOBAL MEDICAL PRODS, INC. 2230 NURSERY RD. UNIT D41 Clearwater, FL 34624 |
Contact | Donald F Ryan |
Correspondent | Donald F Ryan GLOBAL MEDICAL PRODS, INC. 2230 NURSERY RD. UNIT D41 Clearwater, FL 34624 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-15 |
Decision Date | 1995-10-11 |