510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FMAClass I

Depressor, Tongue, Non-Surgical

21 CFR 880.6230 / General Hospital
FDA source (opens on fda.gov)

FMA is the FDA product code for Depressor, Tongue, Non-Surgical, a class I device type, regulated under 21 CFR 880.6230. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FMA
Device name
Depressor, Tongue, Non-Surgical
Regulation
21 CFR 880.6230
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code FMA

By decision year
5 clearances under product code FMA with a decision year between 1977 and 1999, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FMA by decision year
YearClearances
19771
19821
19831
19841
19991

Applicants with the most clearances

Product code FMA
Applicants holding the most 510(k) clearances under product code FMA
ApplicantClearances
Abco Dealers, Inc.1
Aga Plastic Ind. Com. Ltda.1
Pharmaquest Corp.1
Pharmaseal Div., Baxter Healthcare Corp.1
The Torrent Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 216 companies shown, in name order