The following data is part of a premarket notification filed by Jerome Medical with the FDA for Jms Cervical Traction Device/halo Device.
Device ID | K882877 |
510k Number | K882877 |
Device Name: | JMS CERVICAL TRACTION DEVICE/HALO DEVICE |
Classification | Component, Traction, Invasive |
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 | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-11 |
Decision Date | 1988-09-30 |