The following data is part of a premarket notification filed by Health Care Mfg., Inc. with the FDA for Back Specialist.
Device ID | K944329 |
510k Number | K944329 |
Device Name: | BACK SPECIALIST |
Classification | Table, Powered |
Applicant | HEALTH CARE MFG., INC. 2146 EAST PYTHIAN ST. Springfield, MO 65802 |
Contact | Rodney Moulder |
Correspondent | Rodney Moulder HEALTH CARE MFG., INC. 2146 EAST PYTHIAN ST. Springfield, MO 65802 |
Product Code | INQ |
CFR Regulation Number | 890.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-06 |
Decision Date | 1995-03-15 |