The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Personnel Protective Shield.
Device ID | K871502 |
510k Number | K871502 |
Device Name: | PERSONNEL PROTECTIVE SHIELD |
Classification | Shield, Protective, Personnel |
Applicant | CIS-US, INC. 1983 MARCUS AVE. Lake Success, NY 11042 |
Contact | Malamud, Phd |
Correspondent | Malamud, Phd CIS-US, INC. 1983 MARCUS AVE. Lake Success, NY 11042 |
Product Code | KPY |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-17 |
Decision Date | 1987-05-08 |