The following data is part of a premarket notification filed by Simulaids, Inc. with the FDA for Anti-shock Trousers.
Device ID | K873997 |
510k Number | K873997 |
Device Name: | ANTI-SHOCK TROUSERS |
Classification | Sleeve, Limb, Compressible |
Applicant | SIMULAIDS, INC. P.O. BOX 807, 12 DIXON AVE. Woodstock, NY 12498 |
Contact | Kevin M Sweeney |
Correspondent | Kevin M Sweeney SIMULAIDS, INC. P.O. BOX 807, 12 DIXON AVE. Woodstock, NY 12498 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-01 |
Decision Date | 1987-12-15 |