The following data is part of a premarket notification filed by Controlled Therapeutics Corp. with the FDA for Exusorb(tm) Gel Dressing.
| Device ID | K895606 |
| 510k Number | K895606 |
| Device Name: | EXUSORB(TM) GEL DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CONTROLLED THERAPEUTICS CORP. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Craig E Hammes |
| Correspondent | Craig E Hammes CONTROLLED THERAPEUTICS CORP. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1989-10-19 |