The following data is part of a premarket notification filed by Valentine Intl. Ltd. with the FDA for Iv Pole/stand.
Device ID | K952196 |
510k Number | K952196 |
Device Name: | IV POLE/STAND |
Classification | Stand, Infusion |
Applicant | VALENTINE INTL. LTD. 11FL. NO. 518 SUNGIANG ROAD Taipei, TW |
Contact | Mary Valentine |
Correspondent | Mary Valentine VALENTINE INTL. LTD. 11FL. NO. 518 SUNGIANG ROAD Taipei, TW |
Product Code | FOX |
CFR Regulation Number | 880.6990 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-09 |
Decision Date | 1995-07-31 |