Name: Predicase
Price: 199 USD

K-number	K973972
Device name	PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
Applicant	Perfect Ear
Product code	ESD
Device class	Class I
Decision date	Nov 4, 1997
Decision	Substantially Equivalent
Regulation	874.3300

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Source

View the full FDA submission: accessdata.fda.gov

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PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)

Everything you need for a 510(k) submission. Nothing you don't.