The following data is part of a premarket notification filed by Southwest Technologies, Inc. with the FDA for Elasto-gel Occlusive Dressing.
| Device ID | K872165 |
| 510k Number | K872165 |
| Device Name: | ELASTO-GEL OCCLUSIVE DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | SOUTHWEST TECHNOLOGIES, INC. 1510 CHARLOTTE Kansas City, MO 64108 |
| Contact | Edward I Stout |
| Correspondent | Edward I Stout SOUTHWEST TECHNOLOGIES, INC. 1510 CHARLOTTE Kansas City, MO 64108 |
| Product Code | FRO |
| 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 | 1987-06-05 |
| Decision Date | 1987-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00745713486009 | K872165 | 000 |
| 00745713980002 | K872165 | 000 |
| 00745713982006 | K872165 | 000 |