The following data is part of a premarket notification filed by Keymed (medical & Industrial Equipment), Ltd. with the FDA for Olympus Suction Pump Model Kv-4.
Device ID | K930852 |
510k Number | K930852 |
Device Name: | OLYMPUS SUCTION PUMP MODEL KV-4 |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. KEYMED HOUSE,STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH Essex, GB |
Contact | Roger Gray |
Correspondent | Roger Gray KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. KEYMED HOUSE,STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH Essex, GB |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-18 |
Decision Date | 1994-03-31 |