The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Latex Penrose Drain Tubing.
| Device ID | K821700 |
| 510k Number | K821700 |
| Device Name: | LATEX PENROSE DRAIN TUBING |
| Classification | Tourniquet, Nonpneumatic |
| Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAX |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-06-16 |