The following data is part of a premarket notification filed by Fisher Price with the FDA for Fisher Price Sunjammers.
Device ID | K864399 |
510k Number | K864399 |
Device Name: | FISHER PRICE SUNJAMMERS |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | FISHER PRICE C/O OLSSON & FRANK SUIT 400 1029 VERMONT AVE., NW Washington, DC 20005 |
Contact | David Weeda |
Correspondent | David Weeda FISHER PRICE C/O OLSSON & FRANK SUIT 400 1029 VERMONT AVE., NW Washington, DC 20005 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-06 |
Decision Date | 1986-11-21 |