The following data is part of a premarket notification filed by Controlled Therapeutics Corp. with the FDA for Exusorb Transparent Dressing.
| Device ID | K894274 |
| 510k Number | K894274 |
| Device Name: | EXUSORB TRANSPARENT DRESSING |
| Classification | Tape And Bandage, Adhesive |
| Applicant | CONTROLLED THERAPEUTICS CORP. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Craig Hammes |
| Correspondent | Craig Hammes CONTROLLED THERAPEUTICS CORP. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-22 |
| Decision Date | 1989-08-18 |