The following data is part of a premarket notification filed by Lossing Orthopedic, Inc. with the FDA for The Towered 90/90 Unit.
Device ID | K862874 |
510k Number | K862874 |
Device Name: | THE TOWERED 90/90 UNIT |
Classification | Apparatus, Traction, Non-powered |
Applicant | LOSSING ORTHOPEDIC, INC. 777 HARDING STREET, N.E. M-4 P.O. BOX 18298 Minneapolis, MN 55418 |
Contact | Susan G Wolf |
Correspondent | Susan G Wolf LOSSING ORTHOPEDIC, INC. 777 HARDING STREET, N.E. M-4 P.O. BOX 18298 Minneapolis, MN 55418 |
Product Code | HST |
CFR Regulation Number | 888.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-30 |
Decision Date | 1986-08-07 |