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 |