The following data is part of a premarket notification filed by Jerome Medical with the FDA for Traction Accessories.
Device ID | K844490 |
510k Number | K844490 |
Device Name: | TRACTION ACCESSORIES |
Classification | Accessories, Traction |
Applicant | JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
Contact | Suzanne B Beacher |
Correspondent | Suzanne B Beacher JEROME MEDICAL 102 GAITHER DR. Mt Laurel, NJ 08054 |
Product Code | ILZ |
CFR Regulation Number | 890.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-20 |
Decision Date | 1985-02-21 |