The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Reddick Trocar And Cannula.
Device ID | K911601 |
510k Number | K911601 |
Device Name: | REDDICK TROCAR AND CANNULA |
Classification | Tray, Surgical, Instrument |
Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Lorna K Linville |
Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-10 |
Decision Date | 1991-05-21 |