The following data is part of a premarket notification filed by Jobst Institute, Inc. with the FDA for Gladiator Antishock Pants.
Device ID | K953763 |
510k Number | K953763 |
Device Name: | GLADIATOR ANTISHOCK PANTS |
Classification | Trousers, Anti-shock |
Applicant | JOBST INSTITUTE, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Contact | Angelo R Pereira |
Correspondent | Angelo R Pereira JOBST INSTITUTE, INC. 5825 CARNEGIE BLVD. Charlotte, NC 28209 -4633 |
Product Code | LHX |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-11 |
Decision Date | 1995-11-28 |