The following data is part of a premarket notification filed by Opportunity Resources, Inc. with the FDA for Survival Kit.
Device ID | K950357 |
510k Number | K950357 |
Device Name: | SURVIVAL KIT |
Classification | Latex Patient Examination Glove |
Applicant | OPPORTUNITY RESOURCES, INC. 2891 RUSSELL ST. Missoula, MT 59801 |
Contact | Patrick Collins |
Correspondent | Patrick Collins OPPORTUNITY RESOURCES, INC. 2891 RUSSELL ST. Missoula, MT 59801 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-26 |
Decision Date | 1995-06-22 |