The following data is part of a premarket notification filed by Lincoln Mills, Inc. with the FDA for Lincoln Mills Hip Holder.
Device ID | K885215 |
510k Number | K885215 |
Device Name: | LINCOLN MILLS HIP HOLDER |
Classification | Operating Room Accessories Table Tray |
Applicant | LINCOLN MILLS, INC. MEDICAL PRODUCTS GROUP 510 ROUTE 304 New City, NY 10956 |
Contact | Laico, Md |
Correspondent | Laico, Md LINCOLN MILLS, INC. MEDICAL PRODUCTS GROUP 510 ROUTE 304 New City, NY 10956 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-19 |
Decision Date | 1989-01-13 |