The following data is part of a premarket notification filed by Effner And Spreine Co. with the FDA for Effner Cautery Instruments.
Device ID | K875260 |
510k Number | K875260 |
Device Name: | EFFNER CAUTERY INSTRUMENTS |
Classification | Unit, Cautery, Thermal, Battery-powered |
Applicant | EFFNER AND SPREINE CO. P.O. BOX 191 Port Washington, NY 11050 |
Contact | Inge Hamer |
Correspondent | Inge Hamer EFFNER AND SPREINE CO. P.O. BOX 191 Port Washington, NY 11050 |
Product Code | HQP |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-06-06 |