The following data is part of a premarket notification filed by Opportunity, Inc. with the FDA for Opportunity I.v. Start Kit.
| Device ID | K971093 |
| 510k Number | K971093 |
| Device Name: | OPPORTUNITY I.V. START KIT |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | OPPORTUNITY, INC. 1200 OLD SKOKIE RD. Highland Park, IL 60035 |
| Contact | James S Sanders |
| Correspondent | James S Sanders OPPORTUNITY, INC. 1200 OLD SKOKIE RD. Highland Park, IL 60035 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-09-16 |