The following data is part of a premarket notification filed by Intl. Medical-dental Products Usa, Inc. with the FDA for Gertie Marx Needle.
| Device ID | K931644 |
| 510k Number | K931644 |
| Device Name: | GERTIE MARX NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | INTL. MEDICAL-DENTAL PRODUCTS USA, INC. P.O. BOX 681180 528 PARK AVENUE Park City, UT 84068 |
| Contact | Walter Zohmann |
| Correspondent | Walter Zohmann INTL. MEDICAL-DENTAL PRODUCTS USA, INC. P.O. BOX 681180 528 PARK AVENUE Park City, UT 84068 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1993-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50801902114001 | K931644 | 000 |
| 40801902126175 | K931644 | 000 |
| 20801902114000 | K931644 | 000 |
| 20801902113997 | K931644 | 000 |
| 20801902113980 | K931644 | 000 |
| 20801902113973 | K931644 | 000 |
| 20801902162735 | K931644 | 000 |
| 20801902162711 | K931644 | 000 |
| 20801902168027 | K931644 | 000 |
| 40801902126205 | K931644 | 000 |
| 40801902126236 | K931644 | 000 |
| 50801902113998 | K931644 | 000 |
| 50801902113974 | K931644 | 000 |
| 60801902113988 | K931644 | 000 |
| 30801902113994 | K931644 | 000 |
| 30801902113987 | K931644 | 000 |
| 40801902114004 | K931644 | 000 |
| 40801902113977 | K931644 | 000 |
| 40801902126250 | K931644 | 000 |
| 20801902114178 | K931644 | 000 |