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#
- 1219518
- 3042508254
- 8040278
- 1066741
- 3013055499
- 3016438694
- 3010370500
- 9680515
- 3012447612
- 3015876273
- 1720747
- 3007441485
- 3011600579
- 3008114965
- 8010273
- 3006801265
- 3023657851
- 3005031160
- 3016965929
- 9681642
- 3003956316
- 3005751028
- 3004608878
- 1032347
- 3022320321
- 9614093
- 9611274
- 2134285
- 3015212339
- 9610621
- 3046310097
- 3008812560
- 9680900
- 1833824
- 3003431869
- 1030489
- 3010531060
- 3004641308
- 9614069
- 1526439
- 8010379
- 3005809810
- 3004371426
- 3038718579
- 3005641619
- 1054811
- 3006554912
- 3005823819
- 3006513362
- 8010697
- 3012130008
- 3038503932
- 9680059
- 3005061536
- 3044819802
- 3015259876
- 3009513193
- 3001297506
- 3006215390
- 3005677016
- 3010388970
- 3012725451
- 3009973505
- 3029082594
- 1818910
- 3017521423
- 3015167917
- 2432177
- 9613079
- 3008534770
- 3003334541
- 1422507
- 3005619998
- 9613910
- 3035366890
- 9611112
- 1224360
- 9611579
- 2916714
- 2132732
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