The following data is part of a premarket notification filed by Opportunity, Inc. with the FDA for Opportunity Dressing Change Tray.
| Device ID | K971090 |
| 510k Number | K971090 |
| Device Name: | OPPORTUNITY DRESSING CHANGE TRAY |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| 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 |