The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Disposable Needle Counter (20-720).
| Device ID | K861318 |
| 510k Number | K861318 |
| Device Name: | DISPOSABLE NEEDLE COUNTER (20-720) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Contact | Kathy B Russell |
| Correspondent | Kathy B Russell ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-08 |
| Decision Date | 1986-05-02 |