The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Skin Closure Strip.
| Device ID | K931005 |
| 510k Number | K931005 |
| Device Name: | DUKAL SKIN CLOSURE STRIP |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | DUKAL CORP. 17 CROSSWAY Clinton, NJ 08809 |
| Contact | Joel Cademartori |
| Correspondent | Joel Cademartori DUKAL CORP. 17 CROSSWAY Clinton, NJ 08809 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-26 |
| Decision Date | 1993-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840986021555 | K931005 | 000 |
| 30665973008852 | K931005 | 000 |
| 30665973008845 | K931005 | 000 |
| 20665973008831 | K931005 | 000 |
| 20665973008824 | K931005 | 000 |
| 20665973008817 | K931005 | 000 |
| 20665973008800 | K931005 | 000 |