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#
- 3022862651
- 3004571672
- 3007648354
- 1834379
- 8044098
- 3027339877
- 9612420
- 3015212339
- 3010531060
- 3003418325
- 1720747
- 8010298
- 3017565094
- 9616250
- 1649379
- 3005031160
- 3010375065
- 8040278
- 3012120772
- 3010197239
- 3010370500
- 3003038445
- 1060680
- 3010123256
- 3014207283
- 3036795921
- 3004598675
- 3005180920
- 3014003062
- 3009513193
- 3012267976
- 9614093
- 3015399803
- 9613926
- 2249529
- 3005418651
- 3004111573
- 3012995405
- 3017521423
- 3003435550
- 8010273
- 2133928
- 1835251
- 8010733
- 3011301313
- 3008902714
- 3010667733
- 3012883081
- 3012358417
- 2027467
- 2132732
- 3025603301
- 3005092287
- 1043214
- 9614986
- 3010687973
- 3016438694
- 1221763
- 1222188
- 8010379
- 3012130008
- 3004705187
- 8043971
- 9616088
- 2011171
- 2529846
- 3011499367
- 1421879
- 3004892425
- 9680735
- 9710524
- 2936485
- 3015974593
- 1000426080
- 3010097171
- 3005874553
- 3027556548
- 3010303097
- 3034525
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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