510(k) K820659
- Device
- A CALIPER
- Applicant
- TWIN CITY SURGICAL, INC.
- 510(k) number
- K820659
- Product code
- KTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-19
- Date received
- 1982-03-10
- Regulation
- 888.4150
- Classification name
- Caliper
- 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#
- 3003304980
- 3010667733
- 3034676720
- 3005528784
- 3004168759
- 3005325790
- 3004176895
- 3025603301
- 3003882387
- 9611274
- 2132732
- 3004638600
- 3001297506
- 1043534
- 3013552516
- 3008114965
- 1066741
- 3011513267
- 3038718579
- 3010197239
- 3015512299
- 9611367
- 3004608878
- 1644408
- 3012995405
- 9611112
- 3021666757
- 2529846
- 3011683674
- 8010379
- 3012329926
- 1923569
- 3005809810
- 9613910
- 3045855232
- 3044819802
- 8043507
- 9610612
- 3018094310
- 2182762
- 1020279
- 3003431869
- 9680002
- 1224360
- 3015167917
- 1032347
- 3004598675
- 2432177
- 2084346
- 1818910
- 3003407244
- 3010455030
- 3015876273
- 1816267
- 3003956316
- 3004892425
- 3017410889
- 3005726885
- 9614093
- 1054811
- 9680619
- 9614069
- 3005823819
- 3009590742
- 3006395932
- 9710524
- 1222742
- 1422507
- 3017264244
- 3006128100
- 3015259876
- 2431166
- 1219655
- 9611827
- 3010536692
- 3007366790
- 3007773213
- 3009887475
- 3006513362
- 3004641308
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Nk Biotechnical Engineering Co. | 1992-07-14 |
| K841687 | SKYNDEX ELECTRONIC BODY FAT CALCULA | Caldwell, Justiss & Co., Inc. | 1984-06-28 |
| K831898 | SCOLIMETER | Dr. Micheal A. Sabia | 1983-07-19 |
| K810116 | ISOROBIC SKINFOLD CALIPER | Fitness Motivation Institute of America | 1981-02-04 |
| K800363 | PARKE-DAVIS TOTAL KNEE PROSTHESIS | Warner-Lambert Co. | 1980-03-10 |
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