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#
- 3005677016
- 3023657851
- 9611112
- 3008583793
- 3038718579
- 9616671
- 2431166
- 2249529
- 8043507
- 3004638600
- 3005726885
- 2182762
- 3006059835
- 1421879
- 3019356409
- 3004892425
- 1834379
- 3016438694
- 1816267
- 8040278
- 1923569
- 1058152
- 1020279
- 9611827
- 9611579
- 3015212339
- 3009888740
- 1833824
- 3005751028
- 3006846753
- 3005031160
- 3004598675
- 1226544
- 1054811
- 3009106092
- 3004641308
- 3003304980
- 3010455030
- 3005641619
- 1822565
- 3009973336
- 3015895045
- 1030489
- 3020155054
- 3004176895
- 3005273623
- 8010697
- 9613910
- 3001297506
- 3027556548
- 2133928
- 1032347
- 3004142400
- 3004168759
- 3012725451
- 9681642
- 3012329926
- 3006128100
- 1221763
- 1219518
- 3006215390
- 3006801265
- 3010667733
- 3010097171
- 3008455034
- 3029082594
- 9680515
- 1526439
- 1419489
- 2027148
- 3003956316
- 3015876273
- 2529846
- 1422507
- 3009760038
- 1219655
- 1222742
- 9611390
- 2027467
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