The following data is part of a premarket notification filed by Sscor with the FDA for S-scort...jr Quickdraw, Model 2400.
| Device ID | K041154 |
| 510k Number | K041154 |
| Device Name: | S-SCORT...JR QUICKDRAW, MODEL 2400 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SSCOR 11064 RANDALL ST. Sun Valley, CA 91352 |
| Contact | Sam D Say |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-05-18 |
| Summary: | summary |