510(k) K863326
- Device
- BONE MARROW TRAY
- Applicant
- PACKAGING TECHNOLOGIES, INC.
- 510(k) number
- K863326
- Product code
- GAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-16
- Date received
- 1986-08-27
- Regulation
- 878.4800
- Classification name
- Needle, Aspiration And Injection, Disposable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT W FAIR
- Address
- 262 Gemini Ave. Brea CA US 92621 92621
FDA Registration Numbers#
- 3014761220
- 3004168759
- 3002808022
- 3008132398
- 1048735
- 1047843
- 3013298431
- 3009417901
- 3003418325
- 3034667025
- 1721504
- 3009217531
- 3044026004
- 3009746061
- 1625425
- 1319639
- 3015620563
- 1213809
- 3014769442
- 3015142721
- 3013466775
- 3012314549
- 3005216725
- 3003807268
- 3035708926
- 1643817
- 3007344957
- 3014420084
- 1828424
- 9614709
- 1644312
- 3013576619
- 3015077548
- 1224960
- 1064005
- 3009337401
- 1911916
- 3007597038
- 9615588
- 3009265194
- 1820334
- 1220592
- 3019878714
- 3005273623
- 3008258694
- 3009513193
- 3018094310
- 3029905131
- 9617616
- 3007329020
- 3007527549
- 3007017524
- 1720929
- 3011707784
- 1000614268
- 8010312
- 3032327991
- 3008439467
- 3031233007
- 1417592
- 3016904853
- 8030607
- 3038294399
- 3008785630
- 3006425876
- 3012421607
- 1061124
- 3005676736
- 9611446
- 1018233
- 1055236
- 3010097171
- 3006082230
- 3004111573
- 3007417132
- 1017768
- 3011280379
- 3005853033
- 3033589330
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223625 | CapnoSpot™ Pneumothorax Decompression Indicator | Pneumeric, Inc. | 2023-03-28 |
| K102274 | ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT | Arvik Enterprises/ Mini Lap Technologies | 2011-06-15 |
| K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | Diametrics Medical, Inc. | 2001-11-16 |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Ximed/Prosure/Injectx | 2000-03-01 |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Ximed/Prosure/Injectx | 1998-12-11 |
| K974741 | MANAN ACCURA NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 |
| K962425 | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) | Radi Medical Systems AB | 1996-09-11 |
| K961959 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1996-07-19 |
| K945109 | MONOJECT BONE MARROW BIOPSY TRAYS | Sherwood Medical Co. | 1994-11-14 |
| K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Manan Medical Products, Inc. | 1994-02-25 |
| K940025 | MANAN BONE MARROW HARVEST NEEDLES | Manan Medical Products, Inc. | 1994-02-25 |
| K930158 | BONE MARROW BIOPSY PROCEDURE TRAY | Symbiosis Corp. | 1993-07-02 |
| K925621 | IRRIGATION/ASPIRATION TUBING SET | Kirwan Surgical Products, Inc. | 1993-05-07 |
| K924501 | GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-04-20 |
| K925416 | SYMBIOSIS BONE MARROW BIOPSY NEEDLE | Symbiosis Corp. | 1993-02-23 |
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