510(k) K840316
- Device
- CAT 12-ORTHOPEDIC & REHAB DEVICE
- Applicant
- IMM ENTERPRISES LTD.
- 510(k) number
- K840316
- Product code
- HTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-12
- Date received
- 1984-01-24
- Regulation
- 878.4800
- Classification name
- Forceps
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006487092
- 3013901429
- 1423537
- 9617601
- 9614093
- 2029447
- 3011987967
- 3009962553
- 8010769
- 3006563559
- 3034669683
- 3015512299
- 3008711893
- 9611262
- 3005809810
- 3011260488
- 3013596742
- 3010287737
- 3017417635
- 3015060238
- 3036795921
- 3016248634
- 1055890
- 3008110533
- 3026766126
- 1223656
- 9613910
- 2936485
- 2433012
- 1421101
- 3015895045
- 9680059
- 3008467060
- 1054241
- 1644408
- 1928237
- 3002808270
- 8010733
- 3010097171
- 3013273457
- 3002769835
- 1032347
- 1219930
- 3008808042
- 9611665
- 3011530718
- 3010455030
- 3002675176
- 3010055973
- 3025413691
- 8043507
- 8010234
- 8039053
- 3005031160
- 3006272282
- 3009417901
- 3008386507
- 3005921503
- 3004598675
- 3007597038
- 3015393204
- 3009154005
- 3008797953
- 8010300
- 3007589150
- 3002807115
- 3015831087
- 3044466317
- 3012120772
- 3010221586
- 2126670
- 2084346
- 3005621335
- 3015416207
- 3002761766
- 3011625373
- 1820334
- 3012309743
- 3008489813
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HTD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051281 | THE NEEDLE CATCHER | E.D.Medical , Ltd. | 2005-09-08 |
| K974593 | SEMKIN INSULATED BIPOLAR FORCEP | Titan Mfg., Inc. | 1998-06-24 |
| K974594 | SEMKIN BIPOLAR FORCEP | Titan Mfg., Inc. | 1998-06-24 |
| K974595 | CUSHING BAYONET, INSULATED BIPOLAR FORCEP | Titan Mfg., Inc. | 1998-06-24 |
| K913964 | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | Marlo Surgical Technology | 1991-10-23 |
| K911180 | CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS | Northgate Technologies, Inc. | 1991-03-29 |
| K895212 | TIK EXTRAKTOR | Instruments of Sweden, Inc. | 1989-09-27 |
| K890373 | HEMORRHOIDAL FORCEPS | Kinetic Medical Products | 1989-02-03 |
| K890369 | GALL STONE FORCEPS | Kinetic Medical Products | 1989-02-03 |
| K890257 | BONE CUTTING FORCEPS, DOUBLE-ACTION | Kinetic Medical Products | 1989-01-27 |
| K890263 | CILIA FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890262 | LUNG FORCEPS | Kinetic Medical Products | 1989-01-27 |
| K890260 | BONE SHEARS | Kinetic Medical Products | 1989-01-27 |
| K890259 | RIB SHEARS | Kinetic Medical Products | 1989-01-27 |
| K890258 | BONE CUTTING FORCEPS, SINGLE-ACTION | Kinetic Medical Products | 1989-01-27 |
Legacy Summary#
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FDA Review#
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