The following data is part of a premarket notification filed by Kinetic Biomedical Services, Inc. with the FDA for Kinetic Model 132.
Device ID | K891758 |
510k Number | K891758 |
Device Name: | KINETIC MODEL 132 |
Classification | Light, Surgical, Floor Standing |
Applicant | KINETIC BIOMEDICAL SERVICES, INC. 4934 PEACH ST. Erie, PA 16509 |
Contact | James I Laughner |
Correspondent | James I Laughner KINETIC BIOMEDICAL SERVICES, INC. 4934 PEACH ST. Erie, PA 16509 |
Product Code | FSS |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-23 |
Decision Date | 1989-04-19 |