The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Reddick Retractor.
Device ID | K915175 |
510k Number | K915175 |
Device Name: | REDDICK RETRACTOR |
Classification | Retractor |
Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Contact | Lorna Linville |
Correspondent | Lorna Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-15 |
Decision Date | 1992-04-29 |