The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Aspen Esmark Bandage.
Device ID | K872868 |
510k Number | K872868 |
Device Name: | ASPEN ESMARK BANDAGE |
Classification | Bandage, Elastic |
Applicant | ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
Contact | Johnson |
Correspondent | Johnson ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
Product Code | FQM |
CFR Regulation Number | 880.5075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-21 |
Decision Date | 1987-07-31 |