The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Sterigauze Wet Dressing.
Device ID | K952420 |
510k Number | K952420 |
Device Name: | STERIGAUZE WET DRESSING |
Classification | Bandage, Liquid |
Applicant | ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
Contact | Ben Walthall |
Correspondent | Ben Walthall ACACIA LABORATORIES, INC. 1719 SOUTH GRAND AVE. Santa Ana, CA 92705 -4808 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-23 |
Decision Date | 1995-07-12 |