The following data is part of a premarket notification filed by Medpak, Llc with the FDA for Elastic Skin Liquid Bandage.
Device ID | K032948 |
510k Number | K032948 |
Device Name: | ELASTIC SKIN LIQUID BANDAGE |
Classification | Bandage, Liquid |
Applicant | MEDPAK, LLC 568 PARKSIDE COURT Allentown, PA 18104 |
Contact | Joseph G Sant'angelo |
Correspondent | Joseph G Sant'angelo MEDPAK, LLC 568 PARKSIDE COURT Allentown, PA 18104 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-22 |
Decision Date | 2004-06-25 |
Summary: | summary |