The following data is part of a premarket notification filed by Future Medical Products, Inc. with the FDA for Nsd 8cs8 - Tens Device.
Device ID | K892408 |
510k Number | K892408 |
Device Name: | NSD 8CS8 - TENS DEVICE |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | FUTURE MEDICAL PRODUCTS, INC. FEDERAL PLAZA - SUITE 134 300 RABRO DRIVE Hauppauge, NY 11788 |
Contact | Steven Cantor |
Correspondent | Steven Cantor FUTURE MEDICAL PRODUCTS, INC. FEDERAL PLAZA - SUITE 134 300 RABRO DRIVE Hauppauge, NY 11788 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-07 |
Decision Date | 1989-06-23 |