The following data is part of a premarket notification filed by Southwest Technologies, Inc. with the FDA for Elasto-gel Cast & Splint Pads.
| Device ID | K872488 |
| 510k Number | K872488 |
| Device Name: | ELASTO-GEL CAST & SPLINT PADS |
| Classification | Cover, Limb |
| 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 | IPM |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-23 |
| Decision Date | 1987-09-21 |