The following data is part of a premarket notification filed by Charles Polo & Co., Inc. with the FDA for Light, Surgical Accessories.
Device ID | K882132 |
510k Number | K882132 |
Device Name: | LIGHT, SURGICAL ACCESSORIES |
Classification | Light, Surgical, Accessories |
Applicant | CHARLES POLO & CO., INC. P.O. BOX 227 W. Henrietta, NY 14586 |
Contact | Jack Scoville |
Correspondent | Jack Scoville CHARLES POLO & CO., INC. P.O. BOX 227 W. Henrietta, NY 14586 |
Product Code | FTA |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-20 |
Decision Date | 1988-06-15 |