The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Cath Kit, Superpubic.
Device ID | K772227 |
510k Number | K772227 |
Device Name: | CATH KIT, SUPERPUBIC |
Classification | Applicator, Absorbent Tipped, Non-sterile |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXF |
CFR Regulation Number | 880.6025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-06 |
Decision Date | 1977-12-20 |