The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Pulmoguard Disposable Baterial/viral Filter.
Device ID | K934509 |
510k Number | K934509 |
Device Name: | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | SDI DIAGNOSTICS, INC. SHOVEL SHOP SQUARE BUILDING 11 North Easton, MA 02356 |
Contact | Michael J Boyle |
Correspondent | Michael J Boyle SDI DIAGNOSTICS, INC. SHOVEL SHOP SQUARE BUILDING 11 North Easton, MA 02356 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-14 |
Decision Date | 1993-10-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B279F0115040 | K934509 | 000 |
B279F0202080 | K934509 | 000 |
B279F0203050 | K934509 | 000 |
B279F0203100 | K934509 | 000 |
B279F0204050 | K934509 | 000 |
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B279F0205040 | K934509 | 000 |
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B279S297923080 | K934509 | 000 |