The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for Cprotector 2000.
| Device ID | K960587 |
| 510k Number | K960587 |
| Device Name: | CPROTECTOR 2000 |
| Classification | Valve, Non-rebreathing |
| Applicant | CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Contact | Howard Gerson |
| Correspondent | Howard Gerson CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1997-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766588700380 | K960587 | 000 |
| 00766588030012 | K960587 | 000 |
| 00766588030067 | K960587 | 000 |
| 00766588160689 | K960587 | 000 |
| 00766588160702 | K960587 | 000 |
| 00766588160726 | K960587 | 000 |
| 00766588700106 | K960587 | 000 |
| 00766588700113 | K960587 | 000 |
| 00766588700212 | K960587 | 000 |
| 00766588700267 | K960587 | 000 |
| 00766588700304 | K960587 | 000 |
| 00766588700335 | K960587 | 000 |
| 00766588700366 | K960587 | 000 |
| 00766588700373 | K960587 | 000 |
| 00766588030005 | K960587 | 000 |