The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Advanced Wound Dressing.
Device ID | K943781 |
510k Number | K943781 |
Device Name: | ACRYDERM ADVANCED WOUND DRESSING |
Classification | Bandage, Liquid |
Applicant | ACRYMED, INC. 31 WALKING WOODS DR. Lake Oswego, OR 97035 |
Contact | Bruce L Gibbins, Ph.d |
Correspondent | Bruce L Gibbins, Ph.d ACRYMED, INC. 31 WALKING WOODS DR. Lake Oswego, OR 97035 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-03 |
Decision Date | 1994-10-04 |