The following data is part of a premarket notification filed by Hospital Specialty Co. with the FDA for Wound Dressing/abd Pad, Model #10810.
Device ID | K990861 |
510k Number | K990861 |
Device Name: | WOUND DRESSING/ABD PAD, MODEL #10810 |
Classification | Dressing, Wound, Drug |
Applicant | HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland, OH 44103 -4896 |
Contact | John Quigley |
Correspondent | John Quigley HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland, OH 44103 -4896 |
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 | 1999-03-16 |
Decision Date | 1999-04-12 |
Summary: | summary |