The following data is part of a premarket notification filed by Hospital Specialty Co. with the FDA for Clean-sorb.
| Device ID | K941099 |
| 510k Number | K941099 |
| Device Name: | CLEAN-SORB |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-07 |
| Decision Date | 1994-09-30 |