510(k) K863409
- Device
- KUNDIN WOUND GAUGE
- Applicant
- JANE I. KUNDIN
- 510(k) number
- K863409
- Product code
- FTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-29
- Date received
- 1986-09-03
- Regulation
- 878.4800
- Classification name
- Tape, Measuring, Rulers And Calipers
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1288 Laurel Hill Dr. San Mateo CA US 94402 94402
FDA Registration Numbers#
- 3009051471
- 3007703436
- 1319447
- 1526534
- 8044098
- 3010595915
- 3043355002
- 3005809810
- 8043734
- 3010380518
- 2432177
- 3005641619
- 2183449
- 3015451162
- 9613079
- 9611390
- 3002719998
- 3007496191
- 3004837686
- 9611112
- 3014579161
- 3006400329
- 3002808270
- 3007774549
- 2242656
- 3001620590
- 3003700106
- 1055890
- 9680425
- 3009513193
- 8010732
- 8020712
- 3026222938
- 3035678069
- 3012227854
- 3015192261
- 9680825
- 2435946
- 3009468807
- 1060680
- 3012660022
- 9680519
- 3038503932
- 3023155873
- 1018233
- 9680735
- 2436906
- 1828288
- 3013285519
- 9613350
- 3024088964
- 2518410
- 8043965
- 2134812
- 3014662844
- 3007366790
- 9611367
- 1030489
- 3009971621
- 3004784004
- 1937137
- 9615765
- 9611461
- 3005325790
- 3003877407
- 3013734586
- 1048735
- 3015177648
- 3009631939
- 3004992978
- 3002769835
- 3004001706
- 1034876
- 3036756245
- 1420128
- 8010099
- 3004608878
- 3010065126
- 9611502
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160501 | Noxilizer Surgical Ruler | Noxilizer, Inc. | 2016-05-26 |
| K951064 | DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC | S-E Sales & Distribution, Inc. | 1995-05-19 |
| K934930 | OLYMPIC AUTO-LENGTH | Olympic Medical Corp. | 1993-12-29 |
| K932112 | OLYMPIC INFA-LENGTH | Olympic Medical Corp. | 1993-07-22 |
| K883485 | STRYKER PRESSURE MONITOR SYSTEM | Stryker Corp. | 1988-09-13 |
| K880441 | PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. | Plane Iii, Inc. | 1988-02-18 |
| K874352 | TUMORIMETER | Cancer Technologies, Inc. | 1987-11-23 |
| K873470 | TEMPLATE | Cox-Uphuff Intl. | 1987-09-08 |
| K872319 | LN 100 BREAST MARKER | Instrumentation Industries, Inc. | 1987-08-11 |
| K862576 | PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) | Professional Services For Surgeons, Ltd. | 1986-07-15 |
| K860912 | PS2 BRAND MAMMAPLASTY | Professional Services For Surgeons, Ltd. | 1986-03-24 |
| K854892 | RULER | Euro-Med Intl. | 1985-12-24 |
| K840651 | MOLE-MARKER | Notation Systems, Inc. | 1984-03-12 |
| K832899 | ZIMMER OSSIMETER | Zimmer, Inc. | 1983-10-14 |
| K831041 | SAGITTAL KNEE TESTER | Orthopedic Systems, Inc. | 1983-06-24 |
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