The following data is part of a premarket notification filed by Health Care Mfg., Inc. with the FDA for Att-300.
Device ID | K944699 |
510k Number | K944699 |
Device Name: | ATT-300 |
Classification | Equipment, Traction, Powered |
Applicant | HEALTH CARE MFG., INC. 2146 EAST PYTHIAN ST. Springfield, MO 65802 |
Contact | Rosnwy Moulder |
Correspondent | Rosnwy Moulder HEALTH CARE MFG., INC. 2146 EAST PYTHIAN ST. Springfield, MO 65802 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-23 |
Decision Date | 1995-05-26 |