510(k) K812746
- Device
- THORACIC DRAINAGE SET #55-DB2-G
- Applicant
- J. H. EMERSON CO.
- 510(k) number
- K812746
- Product code
- KDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-26
- Date received
- 1981-09-29
- Regulation
- 880.6740
- Classification name
- Bottle, Collection, Vacuum
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3018762668
- 3008388005
- 2024022
- 3038613790
- 3032327991
- 3005739529
- 3013058659
- 3013545067
- 3015924074
- 9611018
- 3014615028
- 1000121056
- 3011175548
- 3027977504
- 3011707784
- 2020550
- 1320894
- 3012316249
- 3015528919
- 3011094311
- 3019794450
- 3017973191
- 2025816
- 3013499315
- 3015142815
- 3006950086
- 3011052946
- 2618282
- 3014252464
- 3044883001
- 3011137372
- 3015967359
- 3012536737
- 3018116884
- 3010402752
- 3030019171
- 3016245364
- 3049808762
- 2024168
- 1319639
- 3010400865
- 1450908
- 3025831202
- 1644312
- 3018130625
- 9710603
- 3008867836
- 3014656668
- 3007681502
- 3027605738
- 9615478
- 3016696686
- 3011816755
- 3020994856
- 3013524793
- 1526534
- 3009683397
- 1721504
- 2515872
- 2183744
- 1056129
- 1422374
- 1062191
- 1928237
- 3005012805
- 3004491689
- 3018503755
- 3038611387
- 3027605322
- 3013404794
- 2916714
- 3011642792
- 3006787036
- 3008507279
- 3005669815
- 2183446
- 3010683450
- 3004365956
- 3022320321
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KDQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081718 | EXPRESS CHEST DRAIN | Atrium Medical Corp. | 2008-07-25 |
| K062302 | MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM | Millicore AB | 2006-10-06 |
| K043582 | OCEAN CHEST DRAIN | Atrium Medical Corp. | 2005-01-21 |
| K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN | Atrium Medical Corp. | 1999-05-05 |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | Deknatel, Inc. | 1996-08-28 |
| K961287 | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM | Rocket Medical Plc | 1996-07-26 |
| K962168 | MUCUS SPECIMEN TRAP | Sage Products, Inc. | 1996-07-22 |
| K950677 | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN | Atrium Medical Corp. | 1995-04-13 |
| K941818 | PM9000 VAC TRAP | Precision Medical, Inc. | 1994-12-12 |
| K932327 | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM | Davol, Inc. | 1993-07-13 |
| K912704 | ATRIUM 2000 CHEST DRAIN | Atrium Medical Corp. | 1991-08-26 |
| K905768 | PLEUR-EVAC CHEST DRAINAGE SYSTEMS | Deknatel, Inc. | 1991-02-11 |
| K897125 | ATRIUM 2000, CHEST DRAIN | Atrium Medical Corp. | 1990-03-30 |
| K896697 | PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI | Deknatel, Inc. | 1990-02-08 |
| K896127 | THORA-KLEX CHEST DRAINAGE UNIT | Davol, Inc. | 1990-01-24 |
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