510(k) K834178
- Device
- H.R. JAKOBI SURG. INSTR. #10 34/36
- Applicant
- IMM ENTERPRISES LTD.
- 510(k) number
- K834178
- Product code
- GWZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-02-23
- Date received
- 1983-11-21
- Regulation
- 882.1700
- Classification name
- Percussor
- Medical specialty
- Neurology
- Review panel
- Neurology
- 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#
- 3014334038
- 3003622639
- 3005809810
- 9710524
- 2435946
- 2081040
- 8043507
- 3004526603
- 9615834
- 3010595915
- 3010812394
- 3006554912
- 3013358456
- 3004001706
- 3003032798
- 3002834291
- 1062671
- 1836161
- 3004892425
- 3010262192
- 8040278
- 8010099
- 3006056044
- 3016170451
- 3010687973
- 8022890
- 8040233
- 1722447
- 1424478
- 3020188747
- 2916714
- 3035708926
- 3006411563
- 8010482
- 3008338766
- 3001084743
- 8010427
- 8040263
- 9611283
- 3004905643
- 3007648354
- 2183585
- 3017805218
- 2022691
- 9614062
- 2432177
- 8030607
- 2434008
- 3007703436
- 3038624873
- 3026875454
- 3003418325
- 3024088964
- 8040179
- 9610612
- 9680874
- 3015069921
- 3005273623
- 9610621
- 3011611571
- 3004450489
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891571 | PERCUSSION HAMMER | Sandal Surgico | 1989-03-31 |
| K852716 | TAYLOR PERCUSSION HAMMER SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-26 |
| K851748 | 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE | Artiberia | 1985-06-13 |
| K834170 | OP-CON SURG. INSTRUMENT #10 | Imm Enterprises , Ltd. | 1984-02-23 |
| K840314 | CAT 10-NEUROLOGY DEVICE | Imm Enterprises , Ltd. | 1984-02-23 |
| K810054 | RICA (DIAGNOSTIC INSTRUMENTS) | Robert I. Chien & Assoc., Inc. | 1981-01-28 |
| K803148 | CONPHAR PERCUSSION HAMMER(TAYLOR) | Conphar, Inc. | 1981-01-08 |
| K803174 | CONPHAR PERCUSSION HAMMER(BUCK TYPE) | Conphar, Inc. | 1980-12-30 |
| K791336 | BUCKS NEUROLOGICAL HAMMER | Amdia Medical Products | 1979-08-03 |
| K791337 | TAYLOR NEUROLOGICAL HAMMER | Amdia Medical Products | 1979-08-03 |
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