The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Abco Instrument Packs & Trays.
| Device ID | K851315 |
| 510k Number | K851315 |
| Device Name: | ABCO INSTRUMENT PACKS & TRAYS |
| Classification | Wrap, Sterilization |
| Applicant | ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
| Contact | Christine Nemeth |
| Correspondent | Christine Nemeth ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-02 |
| Decision Date | 1985-05-01 |