The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Tape, Elastoplast Elastic Tear.
Device ID | K781931 |
510k Number | K781931 |
Device Name: | TAPE, ELASTOPLAST ELASTIC TEAR |
Classification | Bandage, Elastic |
Applicant | BEIERSDORF, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FQM |
CFR Regulation Number | 880.5075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-20 |
Decision Date | 1978-12-07 |