510(k) K160501
- Device
- Noxilizer Surgical Ruler
- Applicant
- Noxilizer,Inc.
- 510(k) number
- K160501
- Product code
- FTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-26
- Date received
- 2016-02-23
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mary Dadone
- Address
- 800 W. Baltimore St. Suite #151 Baltimore MD US 21201 21201
FDA Registration Numbers#
- 2084346
- 1034876
- 3016050940
- 1422634
- 9680718
- 3015895045
- 9616250
- 3004513970
- 1836161
- 9611281
- 9611503
- 1221763
- 3014763043
- 1423662
- 9613350
- 3019455
- 3009106092
- 2132732
- 1526012
- 3009381600
- 3026222938
- 3004824601
- 3000286616
- 9680825
- 3013055499
- 2436906
- 3020468145
- 9613926
- 3004941235
- 3007728266
- 2529846
- 3001297506
- 3014273424
- 3015451828
- 3032109
- 1032347
- 3003039352
- 2183456
- 3042172872
- 3005695838
- 1018233
- 3011371465
- 3003969055
- 3007113487
- 3009973699
- 3001284003
- 3004049923
- 3014326245
- 3010326005
- 3010041511
- 2183744
- 3007774549
- 3012660022
- 8043816
- 3009340886
- 3010470577
- 3005083075
- 2031966
- 2134812
- 2087382
- 9616671
- 9615765
- 3021723305
- 2249529
- 3003761012
- 3008338766
- 3017521423
- 3004425647
- 3004552850
- 2530138
- 2916714
- 3009308092
- 3004111573
- 9611502
- 3007648359
- 3025376090
- 3005528784
- 2135147
- 3015516266
- 3003418325
Source Documents#
Other 510(k) Records For Product Code FTY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K863409 | KUNDIN WOUND GAUGE | Jane I. Kundin | 1986-09-29 |
| 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#
summary
FDA Review#
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