510(k) K921266
- Device
- NK MEDICAL MICROMETER, MODEL MC001
- Applicant
- NK BIOTECHNICAL ENGINEERING CO.
- 510(k) number
- K921266
- Product code
- KTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-14
- Date received
- 1992-03-16
- Regulation
- 888.4150
- Classification name
- Caliper
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN GOTGREDSON
- Address
- P.O. Box 26335 Minneapolis MN US 55426 55426
FDA Registration Numbers#
- 9610612
- 3003334541
- 3018094310
- 3005739886
- 3017521423
- 1822565
- 1720747
- 3015876273
- 3015259876
- 1226544
- 3009790163
- 3015143057
- 8010273
- 3007366790
- 3006801265
- 3004892425
- 3015212339
- 1644408
- 2134285
- 3009887475
- 3006846753
- 9680002
- 9614069
- 3008114965
- 3032747418
- 2084346
- 1419489
- 3011600579
- 3010455030
- 3020155054
- 3005641619
- 3033509898
- 3008812560
- 1066741
- 3009760038
- 8040278
- 3003956316
- 9616086
- 9611367
- 3010667733
- 3015512299
- 3003407244
- 3005677016
- 3009106092
- 3010388970
- 9611390
- 3006215390
- 3007773213
- 3016050940
- 1417592
- 3036756245
- 3034676720
- 8040233
- 3003882387
- 9611112
- 3014662844
- 8010379
- 3006395932
- 3005325790
- 3015207155
- 1219655
- 3009888740
- 3019356409
- 3012995405
- 3005751028
- 3004371426
- 3010370500
- 1645151
- 3019878714
- 9710524
- 1825034
- 3012130008
- 1224360
- 3009973336
- 9611579
- 9611827
- 1058152
- 3004168759
- 1421101
- 2027148
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K841687 | SKYNDEX ELECTRONIC BODY FAT CALCULA | Caldwell, Justiss & Co., Inc. | 1984-06-28 |
| K831898 | SCOLIMETER | Dr. Micheal A. Sabia | 1983-07-19 |
| K820659 | A CALIPER | Twin City Surgical, Inc. | 1982-03-19 |
| K810116 | ISOROBIC SKINFOLD CALIPER | Fitness Motivation Institute of America | 1981-02-04 |
| K800363 | PARKE-DAVIS TOTAL KNEE PROSTHESIS | Warner-Lambert Co. | 1980-03-10 |
| K760521 | TAPE MEASURE | Mcgaw Laboratories | 1976-11-12 |
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