The following data is part of a premarket notification filed by International Medical Development, Inc with the FDA for Imd's Anesthesia Needles (tuohy, Quincke And Pencil Point).
| Device ID | K070354 |
| 510k Number | K070354 |
| Device Name: | IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | INTERNATIONAL MEDICAL DEVELOPMENT, INC 9202 KELLEY DRIVE P.O. BOX 510 Huntsville, UT 84317 |
| Contact | Walter Zohmann |
| Correspondent | Walter Zohmann INTERNATIONAL MEDICAL DEVELOPMENT, INC 9202 KELLEY DRIVE P.O. BOX 510 Huntsville, UT 84317 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B74GM2650I0 | K070354 | 000 |
| B274EP1770 | K070354 | 000 |
| B274EP1760 | K070354 | 000 |
| B274EP1750 | K070354 | 000 |
| B274EP17350 | K070354 | 000 |
| B2742590I0 | K070354 | 000 |
| B2742550I0 | K070354 | 000 |
| B27425160I0 | K070354 | 000 |
| B27425124I0 | K070354 | 000 |
| B27425101I0 | K070354 | 000 |
| B2742490I0 | K070354 | 000 |
| B2742450I0 | K070354 | 000 |
| B27424150I0 | K070354 | 000 |
| B27424124I0 | K070354 | 000 |
| B274GM2190I0 | K070354 | 000 |
| B274GM251601750 | K070354 | 000 |
| B274GM2790I0 | K070354 | 000 |
| B274GM2750I0 | K070354 | 000 |
| B274GM27160I0 | K070354 | 000 |
| B274GM27150I0 | K070354 | 000 |
| B274GM27124I0 | K070354 | 000 |
| B274GM27101I0 | K070354 | 000 |
| B274GM2690I0 | K070354 | 000 |
| B274GM26124I0 | K070354 | 000 |
| B274GM2612417350 | K070354 | 000 |
| B274GM26101I0 | K070354 | 000 |
| B274GM25215I0 | K070354 | 000 |
| B274GM252151770 | K070354 | 000 |
| B274GM251901760 | K070354 | 000 |
| B27424101I0 | K070354 | 000 |