The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Green-line Bipolar Coagulation Unit.
Device ID | K860479 |
510k Number | K860479 |
Device Name: | GREEN-LINE BIPOLAR COAGULATION UNIT |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | GRIESHABER & CO. 1056 TRENTON RD. P.O. BOX 807 Fallisington, PA 19054 |
Contact | John Richmond |
Correspondent | John Richmond GRIESHABER & CO. 1056 TRENTON RD. P.O. BOX 807 Fallisington, PA 19054 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-07 |
Decision Date | 1986-05-01 |