The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Akron Atp9 Traction Machine.
Device ID | K992733 |
510k Number | K992733 |
Device Name: | AKRON ATP9 TRACTION MACHINE |
Classification | Equipment, Traction, Powered |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 RTE. 33 EAST Manalapan, NJ 07726 |
Contact | Audrey Witko |
Correspondent | Audrey Witko HUNTLEIGH TECHNOLOGY, INC. 227 RTE. 33 EAST Manalapan, NJ 07726 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-13 |
Decision Date | 1999-11-10 |
Summary: | summary |