510(k) K800444
- Device
- GOLDEN RETRIEVERS OR SILVER RETRIEVERS
- Applicant
- INSTRUMENT MAKAR, INC.
- 510(k) number
- K800444
- Product code
- HXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-03-05
- Date received
- 1980-02-28
- Regulation
- 888.4540
- Classification name
- Probe
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- 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#
- 3010667733
- 1221934
- 3005528784
- 9610905
- 3025603301
- 3003882387
- 3015383864
- 3010057661
- 3003905396
- 3004983210
- 2521877
- 9611112
- 3005225959
- 1051526
- 9617297
- 2529846
- 9611502
- 3030154790
- 1923569
- 3003032798
- 2242737
- 3009499159
- 1833053
- 9610612
- 3011230048
- 3006891796
- 9680002
- 9680304
- 3008808049
- 3006639944
- 3011137372
- 3015231789
- 3006561161
- 1055236
- 3003407244
- 3021336182
- 1649390
- 3005076207
- 3009380063
- 3013422236
- 3009590742
- 3014003062
- 1643264
- 3010399422
- 3010071016
- 3013546462
- 3013893019
- 1000432246
- 3010047454
- 3007773213
- 3011015572
- 3036756245
- 1226544
- 8043971
- 8010252
- 9611252
- 9616088
- 8010935
- 3004215117
- 1720747
- 1054241
- 1017294
- 8040233
- 3013846070
- 3001408183
- 3004049923
- 2011171
- 1421101
- 3039169546
- 3017486146
- 3011499367
- 3006765019
- 3008455034
- 3009702671
- 3005596514
- 3009340886
- 3010687973
- 3004944585
- 9611390
- 8044098
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960539 | DIAO HAND SURGERY SET | Kinetikos Medical, Inc. | 1996-07-23 |
| K943472 | COHORT AVB RETRACTOR SYSTEM | Cohort Medical Products Group, Inc. | 1994-10-20 |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Flexmedics | 1991-09-24 |
| K890227 | SURGICAL PROBE | Kinetic Medical Products | 1989-01-27 |
| K873651 | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | Arthropedics, Inc. | 1987-11-02 |
| K873652 | HOOK PROBE #TM-1376 | Arthropedics, Inc. | 1987-11-02 |
| K863149 | BOWEN PROBE | Bowen & Company, Inc. | 1986-09-05 |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Stainless Mfg., Inc. | 1984-06-19 |
| K840558 | SHUTT PRECISION PROBES | Concept, Inc. | 1984-04-25 |
| K810294 | LINE CADDY | Instranetics, Inc. | 1981-02-26 |
| K802951 | I.M PROBES | Hogan & Hartson | 1980-12-17 |
| K802479 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1980-10-31 |
| K800729 | PROBE | Stainless Mfg., Inc. | 1980-04-08 |
| K800274 | ACUFEX PROBES | Acufex Microsurgical, Inc. | 1980-02-19 |
Legacy Summary#
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FDA Review#
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