510(k) K933364
- Device
- PROMED BIOPSY NEEDLE
- Applicant
- VLV ASSOCIATES, INC.
- 510(k) number
- K933364
- Product code
- DWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-15
- Date received
- 1993-07-09
- Regulation
- 878.4800
- Classification name
- Needle, Biopsy, Cardiovascular
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- VINCENT L VAILLANCOURT
- Address
- 30c Ridgedale Ave. East Hanover NJ US 07936 07936
FDA Registration Numbers#
- 1123137
- 3027260597
- 1836564
- 1828424
- 3011137372
- 3004749705
- 1646747
- 3004857851
- 3006554912
- 1625425
- 1421879
- 9616662
- 3002807314
- 9612278
- 9617744
- 1048735
- 1836161
- 8040278
- 3015309643
- 3003807268
- 3010041511
- 3008902714
- 3005987240
- 3014761220
- 3003431869
- 3007156625
- 3008770252
- 3012536737
- 3004111573
- 3007597038
- 1820334
- 3033589330
- 8039051
- 9616246
- 2027062
- 3015225571
- 1417485
- 8043816
- 3006897996
- 1721504
- 3005273623
- 9610621
- 3006950086
- 3007146453
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921418 | ULTRA-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1992-06-19 |
| K913815 | AUTOMATED BIOPSY DEVICE, MODIFICATION | Hart Enterprises, Inc. | 1991-10-30 |
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE | Manan Medical Products, Inc. | 1989-04-11 |
| K885145 | MEDSURG GREENE NEEDLE | Medsurg Industries, Inc. | 1989-03-14 |
| K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | Hart Enterprises, Inc. | 1989-01-26 |
| K882013 | SOFT TISSUE BIOPSY DEVICE | Ocean Medical Products, Ltd. | 1988-06-15 |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Angiomed U.S., Inc. | 1987-12-02 |
| K872597 | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE | Dianon Systems, Inc. | 1987-07-28 |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Argon Medical Corp. | 1985-09-12 |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | CIVCO Medical Instruments Co., Inc. | 1982-03-23 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases