The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Blakemore Tube - 4 Lumen (minnesota Type).
| Device ID | K973892 |
| 510k Number | K973892 |
| Device Name: | RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | James R Whitney |
| Correspondent | James R Whitney RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1998-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704030789 | K973892 | 000 |