The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Cap, Tamper Proof Plastic.
Device ID | K782113 |
510k Number | K782113 |
Device Name: | CAP, TAMPER PROOF PLASTIC |
Classification | Container, I.v. |
Applicant | ACACIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-19 |
Decision Date | 1979-06-01 |