510(k) K960405
- Device
- SPINAL NEEDLE
- Applicant
- PROMEX, INC.
- 510(k) number
- K960405
- Product code
- MIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-02-28
- Date received
- 1996-01-29
- Regulation
- 868.5150
- Classification name
- Needle, Spinal, Short Term
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH L MARK
- Address
- 1125 Brookside Ave. Suite G500 Indianapolis IN US 46202 46202
FDA Registration Numbers#
- 1721676
- 3003604053
- 1047429
- 9617604
- 1061124
- 1219602
- 1224960
- 3020983482
- 3012307300
- 1644312
- 3011237704
- 1319639
- 1643059
- 3008132398
- 3004111573
- 1030451
- 3035642068
- 1423537
- 9681709
- 3005941719
- 9616088
- 1721686
- 3004504731
- 1316297
- 3010966701
- 1423507
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MIA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172800 | Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors | Smiths Medical Asd, Inc. | 2018-06-14 |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | Epimed International, Inc. | 2005-08-22 |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Sims Portex, Inc. | 1999-01-29 |
| K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA | Allegiance Healthcare Corp. | 1998-07-23 |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | Avid N.I.T., Inc. | 1997-08-01 |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | Klein-Baker Medical, Inc. | 1997-05-22 |
| K961324 | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES | Global Medical Prods, Inc. | 1996-07-02 |
| K942442 | ACUFEX T-FIX DELIVERY SYSTEM | Acufex Microsurgical, Inc. | 1994-12-05 |
| K904380 | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | Custom Medical Concepts, Inc. | 1993-04-08 |
Legacy Summary#
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FDA Review#
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