The following data is part of a premarket notification filed by Asia-med Gmbh & Co. Kg. - Werk Suhl with the FDA for Press Tack Needle.
| Device ID | K042063 |
| 510k Number | K042063 |
| Device Name: | PRESS TACK NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | ASIA-MED GMBH & CO. KG. - WERK SUHL 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ASIA-MED GMBH & CO. KG. - WERK SUHL 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 | 2004-08-02 |
| Decision Date | 2004-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251282504243 | K042063 | 000 |
| 04251282504212 | K042063 | 000 |
| 04251282504182 | K042063 | 000 |
| 4251282504250 | K042063 | 000 |
| 4251282504229 | K042063 | 000 |
| 4251282504199 | K042063 | 000 |