The following data is part of a premarket notification filed by Opportunity, Inc. with the FDA for Opportunity Inc. General Purpose Tray.
| Device ID | K971062 |
| 510k Number | K971062 |
| Device Name: | OPPORTUNITY INC. GENERAL PURPOSE TRAY |
| Classification | General Surgery Tray |
| 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 | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50649111322844 | K971062 | 000 |