The following data is part of a premarket notification filed by Wy'east Medical Corp. with the FDA for Easy-op, Portable Dental Cart.
Device ID | K882810 |
510k Number | K882810 |
Device Name: | EASY-OP, PORTABLE DENTAL CART |
Classification | Unit, Operative Dental |
Applicant | WY'EAST MEDICAL CORP. P.O. BOX 1625 11487 S.E. HWY 212 Clackamas, OR 97015 |
Contact | David R Cole |
Correspondent | David R Cole WY'EAST MEDICAL CORP. P.O. BOX 1625 11487 S.E. HWY 212 Clackamas, OR 97015 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-07 |
Decision Date | 1988-08-12 |