The following data is part of a premarket notification filed by Professional Medical Products, Inc. with the FDA for Chick Surgical Light.
Device ID | K862010 |
510k Number | K862010 |
Device Name: | CHICK SURGICAL LIGHT |
Classification | Light, Surgical, Accessories |
Applicant | PROFESSIONAL MEDICAL PRODUCTS, INC. P.O. BOX 3288 Greenwood, SC 29648 |
Contact | J. W Sease |
Correspondent | J. W Sease PROFESSIONAL MEDICAL PRODUCTS, INC. P.O. BOX 3288 Greenwood, SC 29648 |
Product Code | FTA |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-28 |
Decision Date | 1986-06-09 |