510(k) K864371
- Device
- SURGICAL SKIN MARKER
- Applicant
- MYOCURE, INC.
- 510(k) number
- K864371
- Product code
- FZZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-17
- Date received
- 1986-11-05
- Regulation
- 878.4660
- Classification name
- Marker, Skin
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- C.JENSEN, M.D.
- Address
- 1736 Flower St. Glendale CA US 91201 91201
FDA Registration Numbers#
- 3005621279
- 3004571672
- 3004519921
- 3007648354
- 3013557562
- 3027285037
- 3013497507
- 3010487482
- 3016159368
- 3017041963
- 3010160370
- 3043012240
- 9610612
- 9611283
- 3003418325
- 3005951296
- 3008770252
- 3009746061
- 3015173212
- 3009308092
- 2011068
- 2242656
- 3006234743
- 3016758972
- 1417592
- 1055236
- 3007517215
- 3040278125
- 9680934
- 9612030
- 1423537
- 2135339
- 2083373
- 3004911384
- 1646747
- 1422443
- 2027062
- 3004513650
- 3004605321
- 9021987
- 2031093
- 2032098
- 3023339256
- 3044150131
- 1060680
- 3019705154
- 2183785
- 3017461134
- 3029754081
- 2126670
- 9680718
- 9610621
- 3009513193
- 3014931612
- 3016659819
- 3015781779
- 3016920799
- 1061124
- 3009656988
- 3004111573
- 3005528784
- 1836161
- 3009865268
- 2245304
- 3031582434
- 3014334038
- 3024988980
- 2434839
- 1056553
- 9680518
- 1420054
- 1054241
- 3008496560
- 8010374
- 3011209798
- 3011371465
- 3010845285
- 3003431869
- 3006380247
- 3010359335
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FZZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042555 | SURGICHIP TAG SURGICAL MARKER | Surgichip, Inc. | 2004-11-09 |
| K915066 | DISPOSABLE SKIN MARKER | American Medical Mfg., Inc. | 1992-05-14 |
| K914759 | BLOOM TRANSPARENT STENCIL | Freckles Publications, Inc. | 1992-04-21 |
| K912730 | ROCKET SURGICAL SKIN MARKING PEN | West Texas Lighthouse For the Blind | 1991-11-07 |
| K905143 | SKIN MARKER | Aesculap, Inc. | 1991-02-06 |
| K904559 | QUALTEX SKIN MARKER | Qualtex, Inc. | 1990-12-13 |
| K896792 | SURGICAL SKIN MARKER | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
| K863280 | DERMAMARKER | Dermacare Products, Inc. | 1986-09-09 |
| K861772 | LASER SKIN MARKER AND MASK WHITE LOTION | Pacific Poly Crafts | 1986-05-21 |
| K844865 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1985-01-14 |
| K843116 | DISPOSABLE SKIN MARKING PEN | E.M. Adams | 1984-08-17 |
| K841085 | SCANLAN COLORMARK SKIN MARKER | Scanlan Intl., Inc. | 1984-06-11 |
| K840820 | SECURLINE SURGICAL SKIN MARKER 1000 | Precision Dynamics Corp. | 1984-04-25 |
| K840470 | SURGISCRIBE MARKING PEN | Surgicot, Inc. | 1984-03-12 |
| K831372 | TLS SURGICAL MARKER | Porex Medical | 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