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 |