The following data is part of a premarket notification filed by Michael M. Knott, M.d. with the FDA for Nosebleed Noseclip.
Device ID | K981966 |
510k Number | K981966 |
Device Name: | NOSEBLEED NOSECLIP |
Classification | Balloon, Epistaxis |
Applicant | MICHAEL M. KNOTT, M.D. 355 ROSE PINE COURT PO BOX 5577 Tahoe City, CA 96145 -5577 |
Contact | Michael M Knott |
Correspondent | Michael M Knott MICHAEL M. KNOTT, M.D. 355 ROSE PINE COURT PO BOX 5577 Tahoe City, CA 96145 -5577 |
Product Code | EMX |
CFR Regulation Number | 874.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-04 |
Decision Date | 1998-08-14 |
Summary: | summary |