The following data is part of a premarket notification filed by Controlled Therapeutics Corp. with the FDA for Exusorb(tm) Dry/wet Dressing.
Device ID | K896176 |
510k Number | K896176 |
Device Name: | EXUSORB(TM) DRY/WET DRESSING |
Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
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 | KOZ |
CFR Regulation Number | 878.4018 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-25 |
Decision Date | 1989-11-24 |