The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Ref. 4102cv Intermediary Tubing, Ref. 4509cv Sterile Zone Kit.
Device ID | K951843 |
510k Number | K951843 |
Device Name: | REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT |
Classification | Arthroscope |
Applicant | FUTURE MEDICAL SYSTEMS, INC. 205 EAST 63RD ST. SUITE 7A New York City, NY 10021 |
Contact | Patrick Janin |
Correspondent | Patrick Janin FUTURE MEDICAL SYSTEMS, INC. 205 EAST 63RD ST. SUITE 7A New York City, NY 10021 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-20 |
Decision Date | 1995-07-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20886705023230 | K951843 | 000 |
30886705023220 | K951843 | 000 |
30886705023060 | K951843 | 000 |
20886705017451 | K951843 | 000 |
20886705017437 | K951843 | 000 |
10886705016358 | K951843 | 000 |
20886705015907 | K951843 | 000 |
20886705017390 | K951843 | 000 |
20886705015761 | K951843 | 000 |