The following data is part of a premarket notification filed by Medcare Products with the FDA for Med-care Emergency Shears.
Device ID | K820170 |
510k Number | K820170 |
Device Name: | MED-CARE EMERGENCY SHEARS |
Classification | Cutter, Surgical |
Applicant | MEDCARE PRODUCTS 217 LONG HILL CROSS RDS Shelton, CT 06484 |
Contact | Thomas F Kiley |
Correspondent | Thomas F Kiley MEDCARE PRODUCTS 217 LONG HILL CROSS RDS Shelton, CT 06484 |
Product Code | FZT |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-21 |
Decision Date | 1982-02-05 |