The following data is part of a premarket notification filed by Stericycle, Inc. with the FDA for Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red, Stericycle Sharps Management Services Reu.
| Device ID | K132007 |
| 510k Number | K132007 |
| Device Name: | STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU |
| Classification | Container, Sharps |
| Applicant | STERICYCLE, INC. 755 N. MATHILDA AVE., SUITE 100 Sunnyvale, CA 94085 |
| Contact | Lori Adels |
| Correspondent | Lori Adels STERICYCLE, INC. 755 N. MATHILDA AVE., SUITE 100 Sunnyvale, CA 94085 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858775006280 | K132007 | 000 |
| 00858775006174 | K132007 | 000 |
| 00858775006167 | K132007 | 000 |
| 00858775006112 | K132007 | 000 |