The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Suboccipital Ice Pillow.
Device ID | K882413 |
510k Number | K882413 |
Device Name: | SUBOCCIPITAL ICE PILLOW |
Classification | Pack, Hot Or Cold, Reusable |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | IME |
CFR Regulation Number | 890.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-13 |
Decision Date | 1988-11-30 |