The following data is part of a premarket notification filed by Asia-med Gmbh And Co Kg with the FDA for Asia-med Acupuncture Needles, (standard, Special, Compact, Apex).
| Device ID | K011808 |
| 510k Number | K011808 |
| Device Name: | ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) |
| 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 | 2001-06-11 |
| Decision Date | 2001-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251282504274 | K011808 | 000 |
| 4251282500443 | K011808 | 000 |
| 4251282500412 | K011808 | 000 |
| 4251282500382 | K011808 | 000 |
| 4251282500351 | K011808 | 000 |
| 4251282500320 | K011808 | 000 |
| 4251282500290 | K011808 | 000 |
| 4251282500269 | K011808 | 000 |
| 4251282500238 | K011808 | 000 |
| 4251282500207 | K011808 | 000 |
| 4251282500177 | K011808 | 000 |
| 4251282500146 | K011808 | 000 |
| 4251282500115 | K011808 | 000 |
| 4251282500085 | K011808 | 000 |
| 4251282500054 | K011808 | 000 |
| 04251282500016 | K011808 | 000 |
| 04251282500047 | K011808 | 000 |
| 04251282500467 | K011808 | 000 |
| 04251282500436 | K011808 | 000 |
| 04251282500405 | K011808 | 000 |
| 04251282500375 | K011808 | 000 |
| 04251282500344 | K011808 | 000 |
| 04251282500313 | K011808 | 000 |
| 04251282500283 | K011808 | 000 |
| 04251282500252 | K011808 | 000 |
| 04251282500221 | K011808 | 000 |
| 04251282500191 | K011808 | 000 |
| 04251282500160 | K011808 | 000 |
| 04251282500139 | K011808 | 000 |
| 04251282500108 | K011808 | 000 |
| 04251282500078 | K011808 | 000 |
| 4251282500023 | K011808 | 000 |