The following data is part of a premarket notification filed by Challenge Mfg., Inc. with the FDA for Cmi Vacuum Pump W/#101a Vacuum Pump (auto-clave.).
| Device ID | K895446 |
| 510k Number | K895446 |
| Device Name: | CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | CHALLENGE MFG., INC. P.O. BOX 5877 Bend, OR 97708 |
| Contact | Emily Smith |
| Correspondent | Emily Smith CHALLENGE MFG., INC. P.O. BOX 5877 Bend, OR 97708 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-08 |
| Decision Date | 1989-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671101A1 | K895446 | 000 |