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-5.
Device ID | K011725 |
510k Number | K011725 |
Device Name: | OLYMPUS SUCTION PUMP, MODEL KV-5 |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. Southend-on-sea, Essex, GB Ss25qh |
Contact | Roger Gray |
Correspondent | Roger Gray KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. STOCK RD. Southend-on-sea, Essex, GB Ss25qh |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-04 |
Decision Date | 2001-08-31 |