The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Reusable/disposable Autopsy Knife Set.
Device ID | K863549 |
510k Number | K863549 |
Device Name: | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET |
Classification | Knife, Surgical |
Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Contact | Urban, Ht(ascp) |
Correspondent | Urban, Ht(ascp) SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Product Code | EMF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-12 |
Decision Date | 1986-09-30 |