510(k) K931005
- Device
- DUKAL SKIN CLOSURE STRIP
- Applicant
- DUKAL CORP.
- 510(k) number
- K931005
- Product code
- FPX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-14
- Date received
- 1993-02-26
- Regulation
- 880.5240
- Classification name
- Strip, Adhesive, Closure, Skin
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOEL CADEMARTORI
- Address
- 17 Crossway Clinton NJ US 08809 08809
FDA Registration Numbers#
- 1038758
- 9680091
- 3042158718
- 3030226294
- 3003418325
- 1836161
- 3034604687
- 3003636207
- 1423662
- 3034531759
- 3011248163
- 1123137
- 3005761322
- 3011983031
- 3015058854
- 3010881832
- 3014477757
- 3003767891
- 3016837630
- 3017166480
- 3003403221
- 3009655869
- 2435946
- 3024088964
- 3007307589
- 3009548473
- 9680143
- 3017107376
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FPX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | Medi-Flex Hospital Products, Inc. | 1997-05-09 |
| K952947 | DELPORE SKIN CLOSURE | Bitco Intl. | 1995-07-24 |
| K952702 | DERMA SEAL | Ttl Medical | 1995-06-28 |
| K946321 | BIOSTRIP STERILE WOUND CLOSURE STRIP | Cornelia Damsky, Inc. | 1995-01-12 |
| K921775 | SPYROFLEX WOUND CLOSURES | Polymint Industrial Co. , Ltd. | 1992-05-19 |
| K894802 | AWC BUTTERFLY WOUND CLOSURES | American White Cross, Inc. | 1990-01-31 |
| K894205 | TECNOL SILK STRIP | Tecnol New Jersey Wound Care, Inc. | 1989-07-25 |
| K874813 | OMED WOUND CLOSURE STRIPS | Oxboro Medical Intl., Inc. | 1988-01-29 |
| K840945 | SKIN CLOSURE | Gainor Medical | 1984-10-31 |
| K842621 | SUTURE STRIP | Genetic Laboratories, Inc. | 1984-10-25 |
| K833258 | SKIN TECH. SURGI-STRIPS | Lee Tec Corp. | 1984-01-25 |
| K833083 | DERMA STRIP-TM SKIN CLOSURES | Howmedica Corp. | 1983-12-30 |
| K831438 | ELASTOPLAST | Beiersdorf, Inc. | 1983-11-25 |
| K831439 | ELASTOPLAST T.P.N. | Beiersdorf, Inc. | 1983-09-29 |
| K821763 | SHUR-STRIP APPLICATOR | Shur Medical Corp. | 1982-06-23 |
Legacy Summary#
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
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