The following data is part of a premarket notification filed by Leonard Joseph Co. with the FDA for Non-sterile Gauze Roller Bandages.
| Device ID | K852265 |
| 510k Number | K852265 |
| Device Name: | NON-STERILE GAUZE ROLLER BANDAGES |
| Classification | Gauze/sponge, Internal |
| Applicant | LEONARD JOSEPH CO. 1100 WEST 45TH AVE. Denver, CO 80211 |
| Contact | Allan M Striker |
| Correspondent | Allan M Striker LEONARD JOSEPH CO. 1100 WEST 45TH AVE. Denver, CO 80211 |
| 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 | 1985-05-24 |
| Decision Date | 1985-06-18 |