The following data is part of a premarket notification filed by Martin Medical with the FDA for Martin Medical Pro-scope Anoscope.
Device ID | K863273 |
510k Number | K863273 |
Device Name: | MARTIN MEDICAL PRO-SCOPE ANOSCOPE |
Classification | Surgical Instruments, G-u, Manual (and Accessories) |
Applicant | MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
Contact | Randy Kilburn |
Correspondent | Randy Kilburn MARTIN MEDICAL 36270 W. 103RD ST. P.O. BOX 590 Desoto, KS 66018 |
Product Code | KOA |
CFR Regulation Number | 876.4730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-25 |
Decision Date | 1986-11-04 |