The following data is part of a premarket notification filed by D.a. Schulman, Inc. with the FDA for Das Sport Pump(tm).
| Device ID | K883681 |
| 510k Number | K883681 |
| Device Name: | DAS SPORT PUMP(TM) |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | D.A. SCHULMAN, INC. 7701 NEWTON AVE NORTH Brooklyn Park, MN 55444 |
| Contact | A Schulman |
| Correspondent | A Schulman D.A. SCHULMAN, INC. 7701 NEWTON AVE NORTH Brooklyn Park, MN 55444 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-09-30 |