The following data is part of a premarket notification filed by Maanshan Medical Instruments Co., Ltd. with the FDA for Tewa Cj-type, Pj-type, Cb-type And Pb-type Acupuncture Needles For Single Use.
| Device ID | K052846 |
| 510k Number | K052846 |
| Device Name: | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | MAANSHAN MEDICAL INSTRUMENTS CO., LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls MAANSHAN MEDICAL INSTRUMENTS CO., LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-07 |
| Decision Date | 2005-12-22 |