The following data is part of a premarket notification filed by Cameron-miller, Inc. with the FDA for Papillotome Cutting Snare.
Device ID | K781353 |
510k Number | K781353 |
Device Name: | PAPILLOTOME CUTTING SNARE |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | CAMERON-MILLER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-07 |
Decision Date | 1978-10-10 |