The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Amer. Pharmaseal Siliconized Latex.
Device ID | K841544 |
510k Number | K841544 |
Device Name: | AMER. PHARMASEAL SILICONIZED LATEX |
Classification | Catheter, Urological |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-16 |
Decision Date | 1984-07-09 |