The following data is part of a premarket notification filed by J. & Jp., Inc. with the FDA for Anu-rx.
Device ID | K862490 |
510k Number | K862490 |
Device Name: | ANU-RX |
Classification | Device, Thermal, Hemorrhoids |
Applicant | J. & JP., INC. 12555 BISCAYNE BLVD. SUITE 970 North Miami Beach, FL 33181 |
Contact | Jerzy Pohler |
Correspondent | Jerzy Pohler J. & JP., INC. 12555 BISCAYNE BLVD. SUITE 970 North Miami Beach, FL 33181 |
Product Code | LKX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-01 |
Decision Date | 1986-08-18 |