The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Palpatation And Measuring Stick.
Device ID | K911489 |
510k Number | K911489 |
Device Name: | PALPATATION AND MEASURING STICK |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
Contact | Dean Secrest |
Correspondent | Dean Secrest UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-04 |
Decision Date | 1991-07-02 |