The following data is part of a premarket notification filed by Angiosystems, Inc. with the FDA for Arnold-king Pressure Dressing.
Device ID | K864688 |
510k Number | K864688 |
Device Name: | ARNOLD-KING PRESSURE DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | ANGIOSYSTEMS, INC. 1980-D PARKER COURT Stone Mountain, GA 30087 |
Contact | David L Hopkins |
Correspondent | David L Hopkins ANGIOSYSTEMS, INC. 1980-D PARKER COURT Stone Mountain, GA 30087 |
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 | 1986-12-02 |
Decision Date | 1987-01-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816611024904 | K864688 | 000 |