The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Abco Plastic Utensils.
Device ID | K851309 |
510k Number | K851309 |
Device Name: | ABCO PLASTIC UTENSILS |
Classification | Bath, Sitz, Nonpowered |
Applicant | ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
Contact | Christine Memeth |
Correspondent | Christine Memeth ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
Product Code | KTC |
CFR Regulation Number | 890.5125 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-02 |
Decision Date | 1985-07-01 |