The following data is part of a premarket notification filed by Controlled Therapeutics Corp. with the FDA for Exusorb(tm) Granules.
| Device ID | K894996 |
| 510k Number | K894996 |
| Device Name: | EXUSORB(TM) GRANULES |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-09-28 |