The following data is part of a premarket notification filed by Medical Manufacturers Marketing Co. with the FDA for Sterile Surgeons Gloves.
Device ID | K883736 |
510k Number | K883736 |
Device Name: | STERILE SURGEONS GLOVES |
Classification | Surgeon's Gloves |
Applicant | MEDICAL MANUFACTURERS MARKETING CO. 15689 CHEMICAL LN. Huntington Beach, CA 92649 |
Contact | Ronald R Patterson |
Correspondent | Ronald R Patterson MEDICAL MANUFACTURERS MARKETING CO. 15689 CHEMICAL LN. Huntington Beach, CA 92649 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-01 |
Decision Date | 1988-10-12 |