Ace Medical Surgical Instruments

Rongeur, Manual

Ace Medical

The following data is part of a premarket notification filed by Ace Medical with the FDA for Ace Medical Surgical Instruments.

Pre-market Notification Details

• Device ID: K200387
• 510k Number: K200387
• Device Name: Ace Medical Surgical Instruments
• Classification: Rongeur, Manual
• Applicant: Ace Medical 2230 Park Ave. #202 Cincinnati, OH 45206
• Contact: Alex Ebner
• Correspondent: Cassie Petrov; JALEX Medical 28765 Clemens Rd Suite 3 Westlake, OH 44145
• Product Code: HAE
• CFR Regulation Number: 882.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-18
• Decision Date: 2020-07-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840217908559	K200387	000
00840217900201	K200387	000
00840217900218	K200387	000
00840217900225	K200387	000
00840217900232	K200387	000
00840217900249	K200387	000
00840217900256	K200387	000
00840217900263	K200387	000
00840217900270	K200387	000
00840217900287	K200387	000
00840217900294	K200387	000
00840217900300	K200387	000
00840217900317	K200387	000
00840217900324	K200387	000
00840217900331	K200387	000
00840217900195	K200387	000
00840217900188	K200387	000
00840217908603	K200387	000
00840217905268	K200387	000
00840217905275	K200387	000
00840217905282	K200387	000
00840217905299	K200387	000
00840217905305	K200387	000
00840217905206	K200387	000
00840217905213	K200387	000
00840217905220	K200387	000
00840217905237	K200387	000
00840217905244	K200387	000
00840217905251	K200387	000
00840217900096	K200387	000
00840217900171	K200387	000
00840217900348	K200387	000
00840217900355	K200387	000
00840217900362	K200387	000
00840217900539	K200387	000
00840217900546	K200387	000
00840217900553	K200387	000
00840217900560	K200387	000
00840217900577	K200387	000
00840217900584	K200387	000
00840217900591	K200387	000
00840217900607	K200387	000
00840217900102	K200387	000
00840217900119	K200387	000
00840217900126	K200387	000
00840217900133	K200387	000
00840217900140	K200387	000
00840217900157	K200387	000
00840217900522	K200387	000
00840217900515	K200387	000
00840217900379	K200387	000
00840217900386	K200387	000
00840217900393	K200387	000
00840217900409	K200387	000
00840217900416	K200387	000
00840217900423	K200387	000
00840217900430	K200387	000
00840217900447	K200387	000
00840217900454	K200387	000
00840217900461	K200387	000
00840217900478	K200387	000
00840217900485	K200387	000
00840217900492	K200387	000
00840217900508	K200387	000
00840217900164	K200387	000