The following data is part of a premarket notification filed by Certol International, Llc with the FDA for Protector Needle Sheath Prop.
| Device ID | K052725 |
| 510k Number | K052725 |
| Device Name: | PROTECTOR NEEDLE SHEATH PROP |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CERTOL INTERNATIONAL, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward CERTOL INTERNATIONAL, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H816PNS5001 | K052725 | 000 |
| H816PNS1002 | K052725 | 000 |
| H816MPNS5002 | K052725 | 000 |
| H816MPNS1002 | K052725 | 000 |