The following data is part of a premarket notification filed by Hawthorne Products, Inc. with the FDA for Cool Cast(r).
Device ID | K903946 |
510k Number | K903946 |
Device Name: | COOL CAST(R) |
Classification | Component, Cast |
Applicant | HAWTHORNE PRODUCTS, INC. BOX 66, R.D. #2 Dunkirk, IN 47336 |
Contact | Don R Hobson |
Correspondent | Don R Hobson HAWTHORNE PRODUCTS, INC. BOX 66, R.D. #2 Dunkirk, IN 47336 |
Product Code | LGF |
CFR Regulation Number | 888.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-27 |
Decision Date | 1990-12-31 |