The following data is part of a premarket notification filed by Holl Meditronics, Inc. with the FDA for Ilco Infrared Light Coagulator.
Device ID | K911600 |
510k Number | K911600 |
Device Name: | ILCO INFRARED LIGHT COAGULATOR |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | HOLL MEDITRONICS, INC. P.O. BOX 396 Bolton, Ontario, CA L7e 5t3 |
Contact | William H Holl |
Correspondent | William H Holl HOLL MEDITRONICS, INC. P.O. BOX 396 Bolton, Ontario, CA L7e 5t3 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-10 |
Decision Date | 1991-07-09 |