The following data is part of a premarket notification filed by Kick Ice, Inc. with the FDA for Instant Cold Pack.
Device ID | K963666 |
510k Number | K963666 |
Device Name: | INSTANT COLD PACK |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | KICK ICE, INC. P.O. BOX 5519 EKS Johnson City, TN 37603 |
Contact | Victoria M Phillips |
Correspondent | Victoria M Phillips KICK ICE, INC. P.O. BOX 5519 EKS Johnson City, TN 37603 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-13 |
Decision Date | 1996-10-30 |
Summary: | summary |