The following data is part of a premarket notification filed by Alliance Pharmaceutical Corp. with the FDA for Sat Pad(tm).
Device ID | K926416 |
510k Number | K926416 |
Device Name: | SAT PAD(TM) |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | ALLIANCE PHARMACEUTICAL CORP. 3040 SCIENCE PARK RD. San Diego, CA 92121 |
Contact | Gordon L Schooley |
Correspondent | Gordon L Schooley ALLIANCE PHARMACEUTICAL CORP. 3040 SCIENCE PARK RD. San Diego, CA 92121 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-23 |
Decision Date | 1993-05-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850004813249 | K926416 | 000 |
00850004813263 | K926416 | 000 |
00850004813027 | K926416 | 000 |
00850004813041 | K926416 | 000 |
00850004813058 | K926416 | 000 |
00850004813065 | K926416 | 000 |
00850004813072 | K926416 | 000 |
00850004813089 | K926416 | 000 |
00850004813102 | K926416 | 000 |
00850004813140 | K926416 | 000 |
00850004813225 | K926416 | 000 |
10850004813253 | K926416 | 000 |