The following data is part of a premarket notification filed by Kreativ, Inc. with the FDA for Power Block.
| Device ID | K983227 |
| 510k Number | K983227 |
| Device Name: | POWER BLOCK |
| Classification | Dam, Rubber |
| Applicant | KREATIV, INC. 9025 BALBOA AVE. San Diego, CA 92123 |
| Contact | Joseph M Forehand |
| Correspondent | Joseph M Forehand KREATIV, INC. 9025 BALBOA AVE. San Diego, CA 92123 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-15 |
| Decision Date | 1998-12-11 |