The following data is part of a premarket notification filed by Battle Creek Equipment Co. with the FDA for Battle Creek Pillow.
Device ID | K882264 |
510k Number | K882264 |
Device Name: | BATTLE CREEK PILLOW |
Classification | Orthosis, Cervical |
Applicant | BATTLE CREEK EQUIPMENT CO. 307 WEST JACKSON ST. Battle Creek, MI 49017 |
Contact | John W Doty |
Correspondent | John W Doty BATTLE CREEK EQUIPMENT CO. 307 WEST JACKSON ST. Battle Creek, MI 49017 |
Product Code | IQK |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-31 |
Decision Date | 1988-08-09 |