The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Pediatric Europhylic Foley Catheter.
Device ID | K954752 |
510k Number | K954752 |
Device Name: | PEDIATRIC EUROPHYLIC FOLEY CATHETER |
Classification | Catheter, Retention Type, Balloon |
Applicant | REGULATORY & MARKETING SERVICES, INC. 1247 FLORIDA AVE. Palm Harbor, FL 34682 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb REGULATORY & MARKETING SERVICES, INC. 1247 FLORIDA AVE. Palm Harbor, FL 34682 |
Product Code | EZL |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-16 |
Decision Date | 1995-10-30 |