The following data is part of a premarket notification filed by Asia-med Gmbh And Co Kg with the FDA for Special+, S-needle J-type, S-needle B-type.
| Device ID | K031716 |
| 510k Number | K031716 |
| Device Name: | SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | ASIA-MED GMBH AND CO KG 13 RED FOX LN. Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ASIA-MED GMBH AND CO KG 13 RED FOX LN. 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 | 2003-06-03 |
| Decision Date | 2003-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 4251282504700 | K031716 | 000 |
| 4251282505219 | K031716 | 000 |
| 4251282505240 | K031716 | 000 |
| 4251282505271 | K031716 | 000 |
| 4251282505301 | K031716 | 000 |
| 4251282505332 | K031716 | 000 |
| 4251282505363 | K031716 | 000 |
| 4251282505394 | K031716 | 000 |
| 4251282505424 | K031716 | 000 |
| 4251282505455 | K031716 | 000 |
| 4251282506483 | K031716 | 000 |
| 4251282506513 | K031716 | 000 |
| 4251282506544 | K031716 | 000 |
| 4251282506575 | K031716 | 000 |
| 4251282505189 | K031716 | 000 |
| 4251282505158 | K031716 | 000 |
| 4251282505127 | K031716 | 000 |
| 4251282504731 | K031716 | 000 |
| 4251282504762 | K031716 | 000 |
| 4251282504793 | K031716 | 000 |
| 4251282504823 | K031716 | 000 |
| 4251282504854 | K031716 | 000 |
| 4251282504885 | K031716 | 000 |
| 4251282504915 | K031716 | 000 |
| 4251282504946 | K031716 | 000 |
| 4251282504977 | K031716 | 000 |
| 4251282505004 | K031716 | 000 |
| 4251282505035 | K031716 | 000 |
| 4251282505066 | K031716 | 000 |
| 4251282505097 | K031716 | 000 |
| 04251282507282 | K031716 | 000 |
| 04251282507312 | K031716 | 000 |
| 04251282505172 | K031716 | 000 |
| 04251282505202 | K031716 | 000 |
| 04251282505233 | K031716 | 000 |
| 04251282505264 | K031716 | 000 |
| 04251282505295 | K031716 | 000 |
| 04251282505325 | K031716 | 000 |
| 04251282505356 | K031716 | 000 |
| 04251282505387 | K031716 | 000 |
| 04251282505417 | K031716 | 000 |
| 04251282505448 | K031716 | 000 |
| 04251282506469 | K031716 | 000 |
| 04251282506506 | K031716 | 000 |
| 04251282506537 | K031716 | 000 |
| 04251282505141 | K031716 | 000 |
| 04251282505110 | K031716 | 000 |
| 04251282505080 | K031716 | 000 |
| 04251282504694 | K031716 | 000 |
| 04251282504724 | K031716 | 000 |
| 04251282504755 | K031716 | 000 |
| 04251282504786 | K031716 | 000 |
| 04251282504816 | K031716 | 000 |
| 04251282504847 | K031716 | 000 |
| 04251282504878 | K031716 | 000 |
| 04251282504908 | K031716 | 000 |
| 04251282504939 | K031716 | 000 |
| 04251282504960 | K031716 | 000 |
| 04251282504991 | K031716 | 000 |
| 04251282505028 | K031716 | 000 |
| 04251282505059 | K031716 | 000 |
| 04251282506568 | K031716 | 000 |