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#
- 3014334038
- 3008583793
- 3015895045
- 3005739886
- 3004176895
- 2027148
- 8010379
- 1058152
- 3004464325
- 3035366890
- 3000270450
- 3012329926
- 1421879
- 3013055499
- 3010097171
- 9611827
- 1825034
- 3005273623
- 1219518
- 3007366790
- 8043507
- 3009582259
- 2249529
- 3003882387
- 3011499367
- 3006801265
- 3004638600
- 3003418325
- 3009790163
- 3015425095
- 3004168759
- 3005528784
- 3006846753
- 3044819802
- 3009887475
- 3010197239
- 3003407244
- 3042508254
- 3005061536
- 1222742
- 3004774118
- 3045855232
- 1421101
- 3006215390
- 9611367
- 8040278
- 3004598675
- 9610621
- 2133928
- 3027556548
- 1816267
- 9681642
- 3003431869
- 3005619998
- 1043534
- 9610612
- 3006128100
- 3009106092
- 1054811
- 3009590742
- 9614093
- 1032347
- 1219655
- 3008455034
- 3010353847
- 2432177
- 3008770252
- 9614069
- 3005677016
- 3005641619
- 3009888740
- 2182762
- 3036756245
- 3015512299
- 3004371426
- 3014662844
- 8010273
- 3011600579
- 9611579
- 3015259876
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