The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Non-sterile Pregelled Grounding Pad.
Device ID | K761221 |
510k Number | K761221 |
Device Name: | NON-STERILE PREGELLED GROUNDING PAD |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | IPCO CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-07 |
Decision Date | 1977-01-12 |